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FDA 510(k)

CHEM-CHEX BILIRUBIN

K-Number: K902867 · 1990-07-16

ApplicantStreck Laboratories, Inc.
Decision Date1990-07-16
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEM-CHEX BILIRUBIN is the device name listed in this FDA 510(k) record. The listed applicant is Streck Laboratories, Inc.. It received FDA 510(k) clearance on 1990-07-16 under 510(k) number K902867. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHEM-CHEX BILIRUBIN?

CHEM-CHEX BILIRUBIN is a medical device that received FDA 510(k) clearance on 1990-07-16. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K902867.

When did CHEM-CHEX BILIRUBIN receive FDA 510(k) clearance?

CHEM-CHEX BILIRUBIN received FDA 510(k) clearance on 1990-07-16, under 510(k) number K902867.

Who is the listed applicant for CHEM-CHEX BILIRUBIN?

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

What is the FDA product code for CHEM-CHEX BILIRUBIN?

The FDA product code for CHEM-CHEX BILIRUBIN is JJX.

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Other records listing Streck Laboratories, Inc. as applicant

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Related Devices (Code: JJX)

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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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