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FDA 510(k)

GESTE FOLLOW KIT DETERM. OF HPL

K-Number: K802454 · 1980-11-12

ApplicantSyn-Kit, Inc.
Decision Date1980-11-12
Product CodeJMF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GESTE FOLLOW KIT DETERM. OF HPL is the device name listed in this FDA 510(k) record. The listed applicant is Syn-Kit, Inc.. It received FDA 510(k) clearance on 1980-11-12 under 510(k) number K802454. 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 GESTE FOLLOW KIT DETERM. OF HPL?

GESTE FOLLOW KIT DETERM. OF HPL is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is Syn-Kit, Inc.. The 510(k) number is K802454.

When did GESTE FOLLOW KIT DETERM. OF HPL receive FDA 510(k) clearance?

GESTE FOLLOW KIT DETERM. OF HPL received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802454.

Who is the listed applicant for GESTE FOLLOW KIT DETERM. OF HPL?

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

What is the FDA product code for GESTE FOLLOW KIT DETERM. OF HPL?

The FDA product code for GESTE FOLLOW KIT DETERM. OF HPL is JMF.

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Other records listing Syn-Kit, 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.

K861098SEROIDEN STREPTO KIT 'EIKEN'K861631SLIDE CULTURE U 'EIKEN'K854819CPR SLIDE EIKENK854820RA 80 EIKENK853276ASO SLIDE EIKENK843753UROPAPER EIKEN GP

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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, LLCK791854CENTRIA 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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