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FDA 510(k)

AMYLOCHROME STAT SEPARATOR, TEST

K-Number: K790485 · 1979-05-03

ApplicantHoffmann-La Roche, Inc.
Decision Date1979-05-03
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMYLOCHROME STAT SEPARATOR, TEST is the device name listed in this FDA 510(k) record. The listed applicant is Hoffmann-La Roche, Inc.. It received FDA 510(k) clearance on 1979-05-03 under 510(k) number K790485. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMYLOCHROME STAT SEPARATOR, TEST?

AMYLOCHROME STAT SEPARATOR, TEST is a medical device that received FDA 510(k) clearance on 1979-05-03. The listed applicant is Hoffmann-La Roche, Inc.. The 510(k) number is K790485.

When did AMYLOCHROME STAT SEPARATOR, TEST receive FDA 510(k) clearance?

AMYLOCHROME STAT SEPARATOR, TEST received FDA 510(k) clearance on 1979-05-03, under 510(k) number K790485.

Who is the listed applicant for AMYLOCHROME STAT SEPARATOR, TEST?

The FDA 510(k) record lists Hoffmann-La Roche, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMYLOCHROME STAT SEPARATOR, TEST?

The FDA product code for AMYLOCHROME STAT SEPARATOR, TEST is JKA.

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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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