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FDA 510(k)

GESTATE SLIDE EIKEN KIT AGG. METHOD HUM

K-Number: K802450 · 1980-10-31

ApplicantSyn-Kit, Inc.
Decision Date1980-10-31
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GESTATE SLIDE EIKEN KIT AGG. METHOD HUM 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 1980-10-31 under 510(k) number K802450. The device is classified under product code JHJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GESTATE SLIDE EIKEN KIT AGG. METHOD HUM?

GESTATE SLIDE EIKEN KIT AGG. METHOD HUM is a medical device that received FDA 510(k) clearance on 1980-10-31. The listed applicant is Syn-Kit, Inc.. The 510(k) number is K802450.

When did GESTATE SLIDE EIKEN KIT AGG. METHOD HUM receive FDA 510(k) clearance?

GESTATE SLIDE EIKEN KIT AGG. METHOD HUM received FDA 510(k) clearance on 1980-10-31, under 510(k) number K802450.

Who is the listed applicant for GESTATE SLIDE EIKEN KIT AGG. METHOD HUM?

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 GESTATE SLIDE EIKEN KIT AGG. METHOD HUM?

The FDA product code for GESTATE SLIDE EIKEN KIT AGG. METHOD HUM is JHJ.

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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: JHJ)

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.

K972606PREGNACOL PREGNANCY TESTImmunostics Inc.,K921968IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TESTTech-Co, Inc.K935863SAS(TM) DIRECT MONOCLONAL HCGSa Scientific, Inc.K926112ACCUTEX BETA-HCG TESTJ.S. Medical Assoc.K930609SAS(TM) MONOCLONAL HCG-SLIDESa Scientific, Inc.K920716DIRECT PREGNANCY TESTTech-Co, 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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