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FDA 510(k)

REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM

K-Number: K874809 · 1988-01-07

ApplicantBiotrol, USA, Inc.
Decision Date1988-01-07
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Biotrol, USA, Inc.. It received FDA 510(k) clearance on 1988-01-07 under 510(k) number K874809. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM?

REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM is a medical device that received FDA 510(k) clearance on 1988-01-07. The listed applicant is Biotrol, USA, Inc.. The 510(k) number is K874809.

When did REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM receive FDA 510(k) clearance?

REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM received FDA 510(k) clearance on 1988-01-07, under 510(k) number K874809.

Who is the listed applicant for REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM?

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

What is the FDA product code for REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM?

The FDA product code for REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM is JJY.

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Related Devices (Code: JJY)

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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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