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FDA 510(k)

AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328

K-Number: K933086 · 1994-10-31

ApplicantHelena Laboratories
Decision Date1994-10-31
Product CodeJCM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1994-10-31 under 510(k) number K933086. The device is classified under product code JCM. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328?

AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328 is a medical device that received FDA 510(k) clearance on 1994-10-31. The listed applicant is Helena Laboratories. The 510(k) number is K933086.

When did AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328 receive FDA 510(k) clearance?

AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328 received FDA 510(k) clearance on 1994-10-31, under 510(k) number K933086.

Who is the listed applicant for AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328?

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 AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328?

The FDA product code for AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328 is JCM.

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Related Devices (Code: JCM)

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.

K053031EXTENDSURE HBFASC CONTROLCantebury Scientific , Ltd.K011389HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)Canterbury Health LaboratoriesK983704MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINERoche Diagnostic Systems, Inc.K942222QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLSIsolab, Inc.K931234HEMOCARD CONTROL HB-AA, AE, FAA, FAEIsolab, Inc.K924173HEMOCARD(TM) CONTROLIsolab, Inc.

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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