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FDA 510(k)

BIO-SCIENCE LABORATORIES T4 REAGENT

K-Number: K834023 · 1984-01-24

ApplicantBiosan Laboratories, Inc.
Decision Date1984-01-24
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIO-SCIENCE LABORATORIES T4 REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Biosan Laboratories, Inc.. It received FDA 510(k) clearance on 1984-01-24 under 510(k) number K834023. The device is classified under product code CDX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-SCIENCE LABORATORIES T4 REAGENT?

BIO-SCIENCE LABORATORIES T4 REAGENT is a medical device that received FDA 510(k) clearance on 1984-01-24. The listed applicant is Biosan Laboratories, Inc.. The 510(k) number is K834023.

When did BIO-SCIENCE LABORATORIES T4 REAGENT receive FDA 510(k) clearance?

BIO-SCIENCE LABORATORIES T4 REAGENT received FDA 510(k) clearance on 1984-01-24, under 510(k) number K834023.

Who is the listed applicant for BIO-SCIENCE LABORATORIES T4 REAGENT?

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

What is the FDA product code for BIO-SCIENCE LABORATORIES T4 REAGENT?

The FDA product code for BIO-SCIENCE LABORATORIES T4 REAGENT is CDX.

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Other records listing Biosan Laboratories, 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.

K860642PHOTRON VISUAL FIELD ANALYZERK853812PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION)K832763TOBRAMYCIN REAGENTK833193RADIOIMMUNOASSAY, THYROID STIMU. HORMONEK833318NORMAL GOAT SERUMK833191ABNORMAL URINE CONTROL

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Related Devices (Code: CDX)

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.

K961490ELECSYS T4 ASSAYBoehringer Mannheim Corp.K954312ACTIVE THYROXINE RIADiagnostic Systems Laboratories, Inc.K943416DELFIA NEONATAL THYROXINE KITWallac OYK934384AXSYM(TM) TOTAL T4Abbott LaboratoriesK932980TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116Sigma Diagnostics, Inc.K933426STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNOBaxter 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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