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FDA 510(k)

ASSAYED QCS 1,2, CAT. NOS. 970200, 970500

K-Number: K000875 · 2000-04-20

ApplicantBio-Rad
Decision Date2000-04-20
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ASSAYED QCS 1,2, CAT. NOS. 970200, 970500 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 2000-04-20 under 510(k) number K000875. 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 ASSAYED QCS 1,2, CAT. NOS. 970200, 970500?

ASSAYED QCS 1,2, CAT. NOS. 970200, 970500 is a medical device that received FDA 510(k) clearance on 2000-04-20. The listed applicant is Bio-Rad. The 510(k) number is K000875.

When did ASSAYED QCS 1,2, CAT. NOS. 970200, 970500 receive FDA 510(k) clearance?

ASSAYED QCS 1,2, CAT. NOS. 970200, 970500 received FDA 510(k) clearance on 2000-04-20, under 510(k) number K000875.

Who is the listed applicant for ASSAYED QCS 1,2, CAT. NOS. 970200, 970500?

The FDA 510(k) record lists Bio-Rad as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASSAYED QCS 1,2, CAT. NOS. 970200, 970500?

The FDA product code for ASSAYED QCS 1,2, CAT. NOS. 970200, 970500 is JJY.

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Official Source

View on FDA Database →

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

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