Question 1

Who is the manufacturer of CARY 210 SERIES, SPECTROPHOTOMETER?

Accepted Answer

Varian Assoc., Inc. filed the 510(k) submission for CARY 210 SERIES, SPECTROPHOTOMETER (K791102).

Question 2

What is the FDA product code for CARY 210 SERIES, SPECTROPHOTOMETER?

Accepted Answer

JJQ. It is classified under 21 CFR 862.2300 as a Class 1 device in the Clinical Chemistry panel.

Question 3

When was CARY 210 SERIES, SPECTROPHOTOMETER cleared by the FDA?

Accepted Answer

Jul 17, 1979 (decision: SESE).

Question 4

What is the regulatory pathway for CARY 210 SERIES, SPECTROPHOTOMETER?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like CARY 210 SERIES, SPECTROPHOTOMETER?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K791102
Device Name	CARY 210 SERIES, SPECTROPHOTOMETER
Applicant	Varian Assoc., Inc.
Product Code	JJQ · Clinical Chemistry
Decision Date	Jul 17, 1979
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.2300
Device Class	Class 1

CARY 210 SERIES, SPECTROPHOTOMETER

Device Facts

Regulatory Classification

Identification