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FDA 510(k)

SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS)

K-Number: K914462 · 1991-10-23

ApplicantSerono-Baker Diagnostics, Inc.
Decision Date1991-10-23
Product CodeJLS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS) is the device name listed in this FDA 510(k) record. The listed applicant is Serono-Baker Diagnostics, Inc.. It received FDA 510(k) clearance on 1991-10-23 under 510(k) number K914462. 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 SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS)?

SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS) is a medical device that received FDA 510(k) clearance on 1991-10-23. The listed applicant is Serono-Baker Diagnostics, Inc.. The 510(k) number is K914462.

When did SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS) receive FDA 510(k) clearance?

SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS) received FDA 510(k) clearance on 1991-10-23, under 510(k) number K914462.

Who is the listed applicant for SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS)?

The FDA 510(k) record lists Serono-Baker Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS)?

The FDA product code for SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS) is JLS.

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Other records listing Serono-Baker Diagnostics, 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.

K924257TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAYK915164SRI TESTOSTERONE ENZYME IMMUNOASSAYK914886SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)K915602SRI DIGOXIN ENZYME IMMUNOASSAYK912937SR1 FREE T4 ENZYME IMMUNOASSAYK911912SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE)

View all 23 devices →

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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