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FDA 510(k)

HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015

K-Number: K896643 · 1989-12-29

ApplicantMedix Biotech, Inc.
Decision Date1989-12-29
Product CodeCFL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015 is the device name listed in this FDA 510(k) record. The listed applicant is Medix Biotech, Inc.. It received FDA 510(k) clearance on 1989-12-29 under 510(k) number K896643. 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 HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015?

HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015 is a medical device that received FDA 510(k) clearance on 1989-12-29. The listed applicant is Medix Biotech, Inc.. The 510(k) number is K896643.

When did HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015 receive FDA 510(k) clearance?

HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015 received FDA 510(k) clearance on 1989-12-29, under 510(k) number K896643.

Who is the listed applicant for HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015?

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

What is the FDA product code for HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015?

The FDA product code for HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015 is CFL.

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Other records listing Medix Biotech, 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.

K952873MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)K952319CONTRAST & RAPID HCG URINE/SERUM TSTK932482MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010K932758MEDIX BIOTECH BESTEST HCG-URINE TEST KITK925436MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KITK924259MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100

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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.

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