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FDA 510(k)

PRECO PREGNANCY RAPID CARD TEST, HEM #2028

K-Number: K850604 · 1985-04-08

ApplicantPreco, Inc.
Decision Date1985-04-08
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PRECO PREGNANCY RAPID CARD TEST, HEM #2028 is the device name listed in this FDA 510(k) record. The listed applicant is Preco, Inc.. It received FDA 510(k) clearance on 1985-04-08 under 510(k) number K850604. 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 PRECO PREGNANCY RAPID CARD TEST, HEM #2028?

PRECO PREGNANCY RAPID CARD TEST, HEM #2028 is a medical device that received FDA 510(k) clearance on 1985-04-08. The listed applicant is Preco, Inc.. The 510(k) number is K850604.

When did PRECO PREGNANCY RAPID CARD TEST, HEM #2028 receive FDA 510(k) clearance?

PRECO PREGNANCY RAPID CARD TEST, HEM #2028 received FDA 510(k) clearance on 1985-04-08, under 510(k) number K850604.

Who is the listed applicant for PRECO PREGNANCY RAPID CARD TEST, HEM #2028?

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

What is the FDA product code for PRECO PREGNANCY RAPID CARD TEST, HEM #2028?

The FDA product code for PRECO PREGNANCY RAPID CARD TEST, HEM #2028 is JHJ.

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Other records listing Preco, 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.

K853144CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036K852751TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TESTK853054RF CARD TEST

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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