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FDA 510(k)

VMA ASSAY KIT

K-Number: K843379 · 1984-09-28

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1984-09-28
Product CodeCDF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VMA ASSAY KIT 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 1984-09-28 under 510(k) number K843379. The device is classified under product code CDF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VMA ASSAY KIT?

VMA ASSAY KIT is a medical device that received FDA 510(k) clearance on 1984-09-28. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K843379.

When did VMA ASSAY KIT receive FDA 510(k) clearance?

VMA ASSAY KIT received FDA 510(k) clearance on 1984-09-28, under 510(k) number K843379.

Who is the listed applicant for VMA ASSAY KIT?

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 VMA ASSAY KIT?

The FDA product code for VMA ASSAY KIT is CDF.

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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: CDF)

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.

K953077PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEMBeckman Instruments, Inc.K934977MODEL 5500 CEASEsa, Inc.K895288HVA EIA KIT YAMASAYamasa Shoy Co., Ltd.K895287VMA EIA KIT YAMASAYamasa Shoy Co., Ltd.K873372HVA & HOMOVANILLIC ACID BY HPLC METHODBio-RadK861962VANILMANDELIC ACID (VMA) REAGENT SETSterling Diagnostics, 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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