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FDA 510(k)

CHEM-CHEX STAT

K-Number: K961195 · 1996-05-15

ApplicantStreck Laboratories, Inc.
Decision Date1996-05-15
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEM-CHEX STAT 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 1996-05-15 under 510(k) number K961195. 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 STAT?

CHEM-CHEX STAT is a medical device that received FDA 510(k) clearance on 1996-05-15. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K961195.

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

CHEM-CHEX STAT received FDA 510(k) clearance on 1996-05-15, under 510(k) number K961195.

Who is the listed applicant for CHEM-CHEX STAT?

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 STAT?

The FDA product code for CHEM-CHEX STAT is JJY.

Other records listing Streck Laboratories, Inc. as applicant

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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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