DBEST REAGENT STRIP FOR URINALYSIS

• K Number: K973142
• Device Name: DBEST REAGENT STRIP FOR URINALYSIS
• Manufacturer: AMERITEK, INC.
• Date Cleared: 1997-10-20 ( 60 days)
• Product Code: JIL , CDM , CEN , JIN , JIO , JIR , JJB , JMT , JRE , LJX
• Regulation Number: 862.1340
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

dBest reagent strip for Unaly 5.42 Ketone, specific grav 1 1310 uKocytes in the Uring Uro be ren ut 6 17

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device called "dBest Reagent Strip for Urinalysis." This letter grants clearance for the device to be marketed, but does not contain the detailed study information, acceptance criteria, or performance data that would typically be part of the 510(k) submission itself.

Therefore, I cannot provide the requested table and study details. The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976." This indicates that the clearance was based on substantial equivalence to a predicate device, and while performance data would have been part of the original submission to demonstrate this equivalence, it is not present in the provided document.

To obtain the information requested, one would need to access the full 510(k) submission for K973142.

Regulation Number and Section

§ 862.1340 Urinary glucose (nonquantitative) test system.

(a)
Identification. A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.(b)
Classification. Class II.