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FDA 510(k)

IMMOPHASE TM HPL RADIOIMMUNOASSAY

K-Number: K823292 · 1982-12-28

ApplicantCorning Medical & Scientific
Decision Date1982-12-28
Product CodeJMF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMOPHASE TM HPL RADIOIMMUNOASSAY 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 1982-12-28 under 510(k) number K823292. The device is classified under product code JMF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMOPHASE TM HPL RADIOIMMUNOASSAY?

IMMOPHASE TM HPL RADIOIMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1982-12-28. The listed applicant is Corning Medical & Scientific. The 510(k) number is K823292.

When did IMMOPHASE TM HPL RADIOIMMUNOASSAY receive FDA 510(k) clearance?

IMMOPHASE TM HPL RADIOIMMUNOASSAY received FDA 510(k) clearance on 1982-12-28, under 510(k) number K823292.

Who is the listed applicant for IMMOPHASE TM HPL RADIOIMMUNOASSAY?

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 IMMOPHASE TM HPL RADIOIMMUNOASSAY?

The FDA product code for IMMOPHASE TM HPL RADIOIMMUNOASSAY is JMF.

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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: JMF)

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.

K944933IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN)Diagnostic Products Corp.K840588AMERLEX HUMAN PLACENTAL LACTOGENAmersham Corp.K823201HUMAN PLACENTAL LACTOGEN KITDiagnostic Products Corp.K811370NATAL-TEC HPLArmkel, LLCK802454GESTE FOLLOW KIT DETERM. OF HPLSyn-Kit, Inc.K791854CENTRIA HPL RIAUnion Carbide Corp.

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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