FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

FDA 510(k) Search

K Number

K964982

Device Name

VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)

Manufacturer

JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.

Date Cleared

1997-02-20

(70 days)

Product Code

CEP

Regulation Number

862.1485

Intended Use

Device Description

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

N/A

Reference Devices

N/A

AI/ML (Artificial Intelligence / Machine Learning)

N/A

Therapeutic

N/A

Diagnostic

N/A

SaMD (Software as a Medical Device)

N/A

IVD (In Vitro Diagnostic)

N/A

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

N/A

Regulation Number and Section

§ 862.1485 Luteinizing hormone test system.

(a)
Identification. A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

Summary

N/A