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FDA 510(k)

HEMOCARD CONTROL HB-AA, AE, FAA, FAE

K-Number: K931234 · 1993-05-11

ApplicantIsolab, Inc.
Decision Date1993-05-11
Product CodeJCM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOCARD CONTROL HB-AA, AE, FAA, FAE is the device name listed in this FDA 510(k) record. The listed applicant is Isolab, Inc.. It received FDA 510(k) clearance on 1993-05-11 under 510(k) number K931234. 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 HEMOCARD CONTROL HB-AA, AE, FAA, FAE?

HEMOCARD CONTROL HB-AA, AE, FAA, FAE is a medical device that received FDA 510(k) clearance on 1993-05-11. The listed applicant is Isolab, Inc.. The 510(k) number is K931234.

When did HEMOCARD CONTROL HB-AA, AE, FAA, FAE receive FDA 510(k) clearance?

HEMOCARD CONTROL HB-AA, AE, FAA, FAE received FDA 510(k) clearance on 1993-05-11, under 510(k) number K931234.

Who is the listed applicant for HEMOCARD CONTROL HB-AA, AE, FAA, FAE?

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

What is the FDA product code for HEMOCARD CONTROL HB-AA, AE, FAA, FAE?

The FDA product code for HEMOCARD CONTROL HB-AA, AE, FAA, FAE is JCM.

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Other records listing Isolab, Inc. as applicant

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.

K951014ISOLAB'S T4 TEST KITK950481NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KITK943547PHENYLALANINE TEST KITK950803ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLEK950415FLUOROSCAN NEONATALK942276QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY

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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.K933086AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328Helena LaboratoriesK924173HEMOCARD(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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