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FDA 510(k)

URIC ACID REFERENCE SERA

K-Number: K780447 · 1978-06-22

ApplicantMacomb Chemical Co.
Decision Date1978-06-22
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URIC ACID REFERENCE SERA is the device name listed in this FDA 510(k) record. The listed applicant is Macomb Chemical Co.. It received FDA 510(k) clearance on 1978-06-22 under 510(k) number K780447. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URIC ACID REFERENCE SERA?

URIC ACID REFERENCE SERA is a medical device that received FDA 510(k) clearance on 1978-06-22. The listed applicant is Macomb Chemical Co.. The 510(k) number is K780447.

When did URIC ACID REFERENCE SERA receive FDA 510(k) clearance?

URIC ACID REFERENCE SERA received FDA 510(k) clearance on 1978-06-22, under 510(k) number K780447.

Who is the listed applicant for URIC ACID REFERENCE SERA?

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

What is the FDA product code for URIC ACID REFERENCE SERA?

The FDA product code for URIC ACID REFERENCE SERA is JIT.

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Other records listing Macomb Chemical Co. as applicant

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Related Devices (Code: JIT)

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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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