FDA 510(k)

PRISMA-C-REACTIVE PROTEIN CALIBRATORS

K-Number: K823417 · 1982-12-09

Decision Date1982-12-09

Product CodeDCK

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

PRISMA-C-REACTIVE PROTEIN CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1982-12-09 under 510(k) number K823417. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRISMA-C-REACTIVE PROTEIN CALIBRATORS?

PRISMA-C-REACTIVE PROTEIN CALIBRATORS is a medical device that received FDA 510(k) clearance on 1982-12-09. The listed applicant is Syva Co.. The 510(k) number is K823417.

When did PRISMA-C-REACTIVE PROTEIN CALIBRATORS receive FDA 510(k) clearance?

PRISMA-C-REACTIVE PROTEIN CALIBRATORS received FDA 510(k) clearance on 1982-12-09, under 510(k) number K823417.

Who is the listed applicant for PRISMA-C-REACTIVE PROTEIN CALIBRATORS?

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

What is the FDA product code for PRISMA-C-REACTIVE PROTEIN CALIBRATORS?

The FDA product code for PRISMA-C-REACTIVE PROTEIN CALIBRATORS is DCK.

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Other records listing Syva Co. as applicant

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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.