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FDA 510(k)

IMMULITE PROGESTERONE

K-Number: K944211 · 1994-12-19

ApplicantDiagnostic Products Corp.
Decision Date1994-12-19
Product CodeJLS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMULITE PROGESTERONE is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 1994-12-19 under 510(k) number K944211. 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 IMMULITE PROGESTERONE?

IMMULITE PROGESTERONE is a medical device that received FDA 510(k) clearance on 1994-12-19. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K944211.

When did IMMULITE PROGESTERONE receive FDA 510(k) clearance?

IMMULITE PROGESTERONE received FDA 510(k) clearance on 1994-12-19, under 510(k) number K944211.

Who is the listed applicant for IMMULITE PROGESTERONE?

The FDA 510(k) record lists Diagnostic Products Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMULITE PROGESTERONE?

The FDA product code for IMMULITE PROGESTERONE is JLS.

Related Clinical Trials

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.

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Other records listing Diagnostic Products Corp. 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.

K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCINK034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN IK033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZERK032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONEK023152IMMULITE 2000 ALLERGEN-SPECIFIC IGEK023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL

View all 321 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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