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FDA 510(k)

GLUCOSE HK-60 ASSAY KIT CAT. #201-39

K-Number: K860625 · 1986-03-17

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1986-03-17
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE HK-60 ASSAY KIT CAT. #201-39 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). It received FDA 510(k) clearance on 1986-03-17 under 510(k) number K860625. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLUCOSE HK-60 ASSAY KIT CAT. #201-39?

GLUCOSE HK-60 ASSAY KIT CAT. #201-39 is a medical device that received FDA 510(k) clearance on 1986-03-17. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K860625.

When did GLUCOSE HK-60 ASSAY KIT CAT. #201-39 receive FDA 510(k) clearance?

GLUCOSE HK-60 ASSAY KIT CAT. #201-39 received FDA 510(k) clearance on 1986-03-17, under 510(k) number K860625.

Who is the listed applicant for GLUCOSE HK-60 ASSAY KIT CAT. #201-39?

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

What is the FDA product code for GLUCOSE HK-60 ASSAY KIT CAT. #201-39?

The FDA product code for GLUCOSE HK-60 ASSAY KIT CAT. #201-39 is CFR.

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Other records listing Diagnostic Chemicals, Ltd. (Usa) 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.

K022538IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25K974874BILIRUBIN-SL (TOTAL) ASSAYK932556AMMONIA ASSAY CAT. NO. 200-02K932766HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)K932555DC-LINEATE CAT. NO. SE-091K925877DC-UIBC-CAL

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Related Devices (Code: CFR)

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.

K253490Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsRoche DiagnosticsK252357Glucose2Abbott IrelandK220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSHRoche DiagnosticsK191899Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsRoche DiagnosticsK170316ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEMAbbott LaboratoriesK153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL IIElitechgroup

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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