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FDA 510(k)

PROLACTIN RIA DIAG. KIT

K-Number: K771656 · 1977-09-22

ApplicantAbbott Laboratories
Decision Date1977-09-22
Product CodeJMF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROLACTIN RIA DIAG. KIT is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1977-09-22 under 510(k) number K771656. 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 PROLACTIN RIA DIAG. KIT?

PROLACTIN RIA DIAG. KIT is a medical device that received FDA 510(k) clearance on 1977-09-22. The listed applicant is Abbott Laboratories. The 510(k) number is K771656.

When did PROLACTIN RIA DIAG. KIT receive FDA 510(k) clearance?

PROLACTIN RIA DIAG. KIT received FDA 510(k) clearance on 1977-09-22, under 510(k) number K771656.

Who is the listed applicant for PROLACTIN RIA DIAG. KIT?

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

What is the FDA product code for PROLACTIN RIA DIAG. KIT?

The FDA product code for PROLACTIN RIA DIAG. KIT is JMF.

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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.K823292IMMOPHASE TM HPL RADIOIMMUNOASSAYCorning Medical & ScientificK823201HUMAN PLACENTAL LACTOGEN KITDiagnostic Products Corp.K811370NATAL-TEC HPLArmkel, LLCK802454GESTE FOLLOW KIT DETERM. OF HPLSyn-Kit, 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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