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FDA 510(k)

PROGESTERONE DIRECT RIA KIT-RADIOIMM

K-Number: K841333 · 1984-05-02

ApplicantBiotecx Laboratories, Inc.
Decision Date1984-05-02
Product CodeJLS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROGESTERONE DIRECT RIA KIT-RADIOIMM is the device name listed in this FDA 510(k) record. The listed applicant is Biotecx Laboratories, Inc.. It received FDA 510(k) clearance on 1984-05-02 under 510(k) number K841333. The device is classified under product code JLS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROGESTERONE DIRECT RIA KIT-RADIOIMM?

PROGESTERONE DIRECT RIA KIT-RADIOIMM is a medical device that received FDA 510(k) clearance on 1984-05-02. The listed applicant is Biotecx Laboratories, Inc.. The 510(k) number is K841333.

When did PROGESTERONE DIRECT RIA KIT-RADIOIMM receive FDA 510(k) clearance?

PROGESTERONE DIRECT RIA KIT-RADIOIMM received FDA 510(k) clearance on 1984-05-02, under 510(k) number K841333.

Who is the listed applicant for PROGESTERONE DIRECT RIA KIT-RADIOIMM?

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

What is the FDA product code for PROGESTERONE DIRECT RIA KIT-RADIOIMM?

The FDA product code for PROGESTERONE DIRECT RIA KIT-RADIOIMM is JLS.

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Other records listing Biotecx 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.

K982298OPTICOAT T4 EIA KITK981824OPTICOAT T3 EIA KITK895407CORTISOL CLASP-BEAD EIA KITK893620T3 CLASP-BEAD EIA KITK892853T4 CLASP-BEAD EIA KITK883765TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE

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Related Devices (Code: JLS)

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.

K040923LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVAIbl GmbHK973898PROGESTERONE ELISAKmi Diagnostics, Inc.K972133VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)Johnson & Johnson Clinical Diagnostics, Inc.K971725OPUS PROGESTERONEBehring Diagnostics, Inc.K964841ELECSYS PROGESTERONE ASSAYBoehringer Mannheim Corp.K965084VIDAS PROESTERONE (PRG) (30 409)bioMerieux, 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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