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FDA 510(k)

PREGNANCY CARD TEST

K-Number: K852066 · 1985-06-25

ApplicantEm Diagnostic Systems, Inc.
Decision Date1985-06-25
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PREGNANCY CARD TEST is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1985-06-25 under 510(k) number K852066. 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 PREGNANCY CARD TEST?

PREGNANCY CARD TEST is a medical device that received FDA 510(k) clearance on 1985-06-25. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K852066.

When did PREGNANCY CARD TEST receive FDA 510(k) clearance?

PREGNANCY CARD TEST received FDA 510(k) clearance on 1985-06-25, under 510(k) number K852066.

Who is the listed applicant for PREGNANCY CARD TEST?

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

What is the FDA product code for PREGNANCY CARD TEST?

The FDA product code for PREGNANCY CARD TEST is JHJ.

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Other records listing Em Diagnostic Systems, 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.

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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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