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FDA 510(k)

CHEM-CHEX

K-Number: K913687 · 1991-09-19

ApplicantStreck Laboratories, Inc.
Decision Date1991-09-19
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEM-CHEX 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 1991-09-19 under 510(k) number K913687. 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 CHEM-CHEX?

CHEM-CHEX is a medical device that received FDA 510(k) clearance on 1991-09-19. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K913687.

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

CHEM-CHEX received FDA 510(k) clearance on 1991-09-19, under 510(k) number K913687.

Who is the listed applicant for CHEM-CHEX?

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?

The FDA product code for CHEM-CHEX is JJY.

Other records listing Streck Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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