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FDA 510(k)

ALBUMIN STANDARD, #65070

K-Number: K822478 · 1982-09-14

ApplicantEmd Chemicals, Inc.
Decision Date1982-09-14
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALBUMIN STANDARD, #65070 is the device name listed in this FDA 510(k) record. The listed applicant is Emd Chemicals, Inc.. It received FDA 510(k) clearance on 1982-09-14 under 510(k) number K822478. 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 ALBUMIN STANDARD, #65070?

ALBUMIN STANDARD, #65070 is a medical device that received FDA 510(k) clearance on 1982-09-14. The listed applicant is Emd Chemicals, Inc.. The 510(k) number is K822478.

When did ALBUMIN STANDARD, #65070 receive FDA 510(k) clearance?

ALBUMIN STANDARD, #65070 received FDA 510(k) clearance on 1982-09-14, under 510(k) number K822478.

Who is the listed applicant for ALBUMIN STANDARD, #65070?

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

What is the FDA product code for ALBUMIN STANDARD, #65070?

The FDA product code for ALBUMIN STANDARD, #65070 is 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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