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FDA 510(k)

STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY

K-Number: K950570 · 1995-04-11

ApplicantBaxter Diagnostics, Inc.
Decision Date1995-04-11
Product CodeJLS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Diagnostics, Inc.. It received FDA 510(k) clearance on 1995-04-11 under 510(k) number K950570. 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 STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY?

STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1995-04-11. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K950570.

When did STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1995-04-11, under 510(k) number K950570.

Who is the listed applicant for STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY?

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

What is the FDA product code for STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY?

The FDA product code for STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY is JLS.

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Other records listing Baxter 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.

K934458DRIED GRAM-POSITIVE MIC/COMBO PANELSK950817DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCIK935704DRIED GRAM-NEGATIVE MIC//COMBO PANELSK945235DRIED GRAM-POSITIVE MIC/COMBO PANELSK941030DRIED GRAM-NEGATIVE CEFPODOXIMEK940917LORACARBEF GRAM-NAGATIVE PANELS

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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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