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FDA 510(k)

AMER. BIO-SCIENCE LAB T3 REAGENTS

K-Number: K842590 · 1984-08-10

ApplicantAmerican Bio-Science Laboratories
Decision Date1984-08-10
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMER. BIO-SCIENCE LAB T3 REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is American Bio-Science Laboratories. It received FDA 510(k) clearance on 1984-08-10 under 510(k) number K842590. The device is classified under product code CDP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMER. BIO-SCIENCE LAB T3 REAGENTS?

AMER. BIO-SCIENCE LAB T3 REAGENTS is a medical device that received FDA 510(k) clearance on 1984-08-10. The listed applicant is American Bio-Science Laboratories. The 510(k) number is K842590.

When did AMER. BIO-SCIENCE LAB T3 REAGENTS receive FDA 510(k) clearance?

AMER. BIO-SCIENCE LAB T3 REAGENTS received FDA 510(k) clearance on 1984-08-10, under 510(k) number K842590.

Who is the listed applicant for AMER. BIO-SCIENCE LAB T3 REAGENTS?

The FDA 510(k) record lists American Bio-Science Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMER. BIO-SCIENCE LAB T3 REAGENTS?

The FDA product code for AMER. BIO-SCIENCE LAB T3 REAGENTS is CDP.

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Other records listing American Bio-Science Laboratories 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.

K842455AMER. BIO-SCIENCE LAB CORTISOL REAGENT

Related Devices (Code: CDP)

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.

K001607REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)Repromedix Corp.K991692CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.K991252AIA-PACK FT3 ASSAYTosoh Medics, Inc.K981824OPTICOAT T3 EIA KITBiotecx Laboratories, Inc.K983439ABBOTT ARCHITECT FREE T3Abbott Laboratories

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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