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FDA 510(k)

PREG-KNOW

K-Number: K821552 · 1982-06-11

ApplicantImmuno Pathology Labs
Decision Date1982-06-11
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PREG-KNOW is the device name listed in this FDA 510(k) record. The listed applicant is Immuno Pathology Labs. It received FDA 510(k) clearance on 1982-06-11 under 510(k) number K821552. 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 PREG-KNOW?

PREG-KNOW is a medical device that received FDA 510(k) clearance on 1982-06-11. The listed applicant is Immuno Pathology Labs. The 510(k) number is K821552.

When did PREG-KNOW receive FDA 510(k) clearance?

PREG-KNOW received FDA 510(k) clearance on 1982-06-11, under 510(k) number K821552.

Who is the listed applicant for PREG-KNOW?

The FDA 510(k) record lists Immuno Pathology Labs as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREG-KNOW?

The FDA product code for PREG-KNOW is JHJ.

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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