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FDA 510(k)

REP(TM) CK-2 STAT KIT, CAT. NO. 3074

K-Number: K893007 · 1989-07-20

ApplicantHelena Laboratories
Decision Date1989-07-20
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REP(TM) CK-2 STAT KIT, CAT. NO. 3074 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1989-07-20 under 510(k) number K893007. The device is classified under product code CGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REP(TM) CK-2 STAT KIT, CAT. NO. 3074?

REP(TM) CK-2 STAT KIT, CAT. NO. 3074 is a medical device that received FDA 510(k) clearance on 1989-07-20. The listed applicant is Helena Laboratories. The 510(k) number is K893007.

When did REP(TM) CK-2 STAT KIT, CAT. NO. 3074 receive FDA 510(k) clearance?

REP(TM) CK-2 STAT KIT, CAT. NO. 3074 received FDA 510(k) clearance on 1989-07-20, under 510(k) number K893007.

Who is the listed applicant for REP(TM) CK-2 STAT KIT, CAT. NO. 3074?

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

What is the FDA product code for REP(TM) CK-2 STAT KIT, CAT. NO. 3074?

The FDA product code for REP(TM) CK-2 STAT KIT, CAT. NO. 3074 is CGS.

Other records listing Helena Laboratories as applicant

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Related Devices (Code: CGS)

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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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