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FDA 510(k)

QUANTIMETRIC 2 C-REACTIVE PROTEIN REAG.

K-Number: K821984 · 1982-07-22

ApplicantKallestad Laboratories, Inc.
Decision Date1982-07-22
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTIMETRIC 2 C-REACTIVE PROTEIN REAG. is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Laboratories, Inc.. It received FDA 510(k) clearance on 1982-07-22 under 510(k) number K821984. 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 QUANTIMETRIC 2 C-REACTIVE PROTEIN REAG.?

QUANTIMETRIC 2 C-REACTIVE PROTEIN REAG. is a medical device that received FDA 510(k) clearance on 1982-07-22. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K821984.

When did QUANTIMETRIC 2 C-REACTIVE PROTEIN REAG. receive FDA 510(k) clearance?

QUANTIMETRIC 2 C-REACTIVE PROTEIN REAG. received FDA 510(k) clearance on 1982-07-22, under 510(k) number K821984.

Who is the listed applicant for QUANTIMETRIC 2 C-REACTIVE PROTEIN REAG.?

The FDA 510(k) record lists Kallestad Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUANTIMETRIC 2 C-REACTIVE PROTEIN REAG.?

The FDA product code for QUANTIMETRIC 2 C-REACTIVE PROTEIN REAG. is DCK.

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Official Source

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