FDA 510(k)

NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3

K-Number: K962997 · 1996-08-15

Decision Date1996-08-15

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3 is the device name listed in this FDA 510(k) record. The listed applicant is Nova Biomedical Corp.. It received FDA 510(k) clearance on 1996-08-15 under 510(k) number K962997. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3?

NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3 is a medical device that received FDA 510(k) clearance on 1996-08-15. The listed applicant is Nova Biomedical Corp.. The 510(k) number is K962997.

When did NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3 receive FDA 510(k) clearance?

NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3 received FDA 510(k) clearance on 1996-08-15, under 510(k) number K962997.

Who is the listed applicant for NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3?

The FDA 510(k) record lists Nova Biomedical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3?

The FDA product code for NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3 is JJY.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.