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FDA 510(k)

H-I-M-TEST FOR DETECTING HUMAN CHOR. GON

K-Number: K800055 · 1980-01-29

ApplicantTechnam, Inc.
Decision Date1980-01-29
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

H-I-M-TEST FOR DETECTING HUMAN CHOR. GON is the device name listed in this FDA 510(k) record. The listed applicant is Technam, Inc.. It received FDA 510(k) clearance on 1980-01-29 under 510(k) number K800055. 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 H-I-M-TEST FOR DETECTING HUMAN CHOR. GON?

H-I-M-TEST FOR DETECTING HUMAN CHOR. GON is a medical device that received FDA 510(k) clearance on 1980-01-29. The listed applicant is Technam, Inc.. The 510(k) number is K800055.

When did H-I-M-TEST FOR DETECTING HUMAN CHOR. GON receive FDA 510(k) clearance?

H-I-M-TEST FOR DETECTING HUMAN CHOR. GON received FDA 510(k) clearance on 1980-01-29, under 510(k) number K800055.

Who is the listed applicant for H-I-M-TEST FOR DETECTING HUMAN CHOR. GON?

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

What is the FDA product code for H-I-M-TEST FOR DETECTING HUMAN CHOR. GON?

The FDA product code for H-I-M-TEST FOR DETECTING HUMAN CHOR. GON is JHJ.

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Other records listing Technam, 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.

K801509HI-M-TEST FOR METHADONE TEST #2K791551HI-M-TEST MORPHINE

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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