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FDA 510(k)

CHEM-CHEX STAT (NEW)

K-Number: K982290 · 1998-07-22

ApplicantStreck Laboratories, Inc.
Decision Date1998-07-22
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEM-CHEX STAT (NEW) 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 1998-07-22 under 510(k) number K982290. 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 (NEW)?

CHEM-CHEX STAT (NEW) is a medical device that received FDA 510(k) clearance on 1998-07-22. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K982290.

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

CHEM-CHEX STAT (NEW) received FDA 510(k) clearance on 1998-07-22, under 510(k) number K982290.

Who is the listed applicant for CHEM-CHEX STAT (NEW)?

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 (NEW)?

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

Other records listing Streck Laboratories, Inc. as applicant

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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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