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FDA 510(k)

REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207

K-Number: K893224 · 1989-06-20

ApplicantHelena Laboratories
Decision Date1989-06-20
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1989-06-20 under 510(k) number K893224. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207?

REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207 is a medical device that received FDA 510(k) clearance on 1989-06-20. The listed applicant is Helena Laboratories. The 510(k) number is K893224.

When did REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207 receive FDA 510(k) clearance?

REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207 received FDA 510(k) clearance on 1989-06-20, under 510(k) number K893224.

Who is the listed applicant for REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207?

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 GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207?

The FDA product code for REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207 is LCP.

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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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