Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DAC-CEL HCG-MCA KIT RD52

K-Number: K831073 · 1983-09-01

ApplicantWellcome Diagnostics
Decision Date1983-09-01
Product CodeCFL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DAC-CEL HCG-MCA KIT RD52 is the device name listed in this FDA 510(k) record. The listed applicant is Wellcome Diagnostics. It received FDA 510(k) clearance on 1983-09-01 under 510(k) number K831073. The device is classified under product code CFL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DAC-CEL HCG-MCA KIT RD52?

DAC-CEL HCG-MCA KIT RD52 is a medical device that received FDA 510(k) clearance on 1983-09-01. The listed applicant is Wellcome Diagnostics. The 510(k) number is K831073.

When did DAC-CEL HCG-MCA KIT RD52 receive FDA 510(k) clearance?

DAC-CEL HCG-MCA KIT RD52 received FDA 510(k) clearance on 1983-09-01, under 510(k) number K831073.

Who is the listed applicant for DAC-CEL HCG-MCA KIT RD52?

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

What is the FDA product code for DAC-CEL HCG-MCA KIT RD52?

The FDA product code for DAC-CEL HCG-MCA KIT RD52 is CFL.

Other records listing Wellcome Diagnostics 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.

K915203D-DIMER WELLCOTEST (HA10)K910797STREPTEX ACID EXTRACTION KITK895461WELLCOLEX COLOUR SHIGELLA TEST ZC51K890146WELLCOLEX COLOUR SALMONELLA TEST ZL 50K875311WELLCOZYME HSV WZO2K861628WELLCOZYME ROTAVIRUS WZ01

View all 28 devices →

Related Devices (Code: CFL)

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.

K972761SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAYSealite Sciences, Inc.K971353DSL ACTIVE NON-EXTRACTION IGF-I ELISADiagnostic Systems Laboratories, Inc.K970701DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)Diagnostic Systems Laboratories, Inc.K962758DSL 9100 IGF-II IRMADiagnostic Systems Laboratories, Inc.K961678HUMAN GROWTH HORMONE IMMUNOASSAY KITNichols Institute DiagnosticsK961172DSL ACTIVE NON-EXTRACTION IGF-I IRMADiagnostic Systems Laboratories, 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.

↑