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FDA 510(k)

SICKLE-CHECK

K-Number: K820037 · 1982-02-04

ApplicantDiagnostic Technology, Inc.
Decision Date1982-02-04
Product CodeJCM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SICKLE-CHECK is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Technology, Inc.. It received FDA 510(k) clearance on 1982-02-04 under 510(k) number K820037. 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 SICKLE-CHECK?

SICKLE-CHECK is a medical device that received FDA 510(k) clearance on 1982-02-04. The listed applicant is Diagnostic Technology, Inc.. The 510(k) number is K820037.

When did SICKLE-CHECK receive FDA 510(k) clearance?

SICKLE-CHECK received FDA 510(k) clearance on 1982-02-04, under 510(k) number K820037.

Who is the listed applicant for SICKLE-CHECK?

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

What is the FDA product code for SICKLE-CHECK?

The FDA product code for SICKLE-CHECK is JCM.

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Other records listing Diagnostic Technology, 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.

K896378LYME-CHECK(TM) TEST KITK903612EBV/EA-CHECK TM TEST KITK890819HSV-CHECK(TM) TEST KITK891542EBNA-CHECK(TM) TEST KITK890639RESUBMITTED EBV/IGM-CHECK TEST KITK871373EBV-CHECK(TM) TEST KIT (IGG)

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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 LaboratoriesK931234HEMOCARD CONTROL HB-AA, AE, FAA, FAEIsolab, 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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