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FDA 510(k)

IMMO PHASE DIRECT PROGESTERONE RADIO-

K-Number: K830880 · 1983-04-18

ApplicantCorning Medical & Scientific
Decision Date1983-04-18
Product CodeJLS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMO PHASE DIRECT PROGESTERONE RADIO- is the device name listed in this FDA 510(k) record. The listed applicant is Corning Medical & Scientific. It received FDA 510(k) clearance on 1983-04-18 under 510(k) number K830880. 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 IMMO PHASE DIRECT PROGESTERONE RADIO-?

IMMO PHASE DIRECT PROGESTERONE RADIO- is a medical device that received FDA 510(k) clearance on 1983-04-18. The listed applicant is Corning Medical & Scientific. The 510(k) number is K830880.

When did IMMO PHASE DIRECT PROGESTERONE RADIO- receive FDA 510(k) clearance?

IMMO PHASE DIRECT PROGESTERONE RADIO- received FDA 510(k) clearance on 1983-04-18, under 510(k) number K830880.

Who is the listed applicant for IMMO PHASE DIRECT PROGESTERONE RADIO-?

The FDA 510(k) record lists Corning Medical & Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMO PHASE DIRECT PROGESTERONE RADIO-?

The FDA product code for IMMO PHASE DIRECT PROGESTERONE RADIO- is JLS.

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Other records listing Corning Medical & Scientific 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.

K875122DISPOSABLE STERILE SYRINGE FILTERSK872273CORNING EASY WASH ELISA PLATESK872076CORNING DISPOSABLE ROLLER BOTTLESK863789CORNING ELISA PLATESK854024CORNING MAGIC MAB HCG RADIOIMMUNOASSAYK853634CORNING CELL WELLS-MULTIPLE WELL PLATES

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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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