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FDA 510(k)

PREG-TEX

K-Number: K790898 · 1979-07-30

ApplicantBiologics Intl., Inc.
Decision Date1979-07-30
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PREG-TEX is the device name listed in this FDA 510(k) record. The listed applicant is Biologics Intl., Inc.. It received FDA 510(k) clearance on 1979-07-30 under 510(k) number K790898. 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-TEX?

PREG-TEX is a medical device that received FDA 510(k) clearance on 1979-07-30. The listed applicant is Biologics Intl., Inc.. The 510(k) number is K790898.

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

PREG-TEX received FDA 510(k) clearance on 1979-07-30, under 510(k) number K790898.

Who is the listed applicant for PREG-TEX?

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

What is the FDA product code for PREG-TEX?

The FDA product code for PREG-TEX is JHJ.

Other records listing Biologics Intl., 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.

K882229AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMSK823353CARCINO-CEKK812060BI-ASO SLIDE TESTK811375BI-RA SLIDE TESTK811374BI-CRP LATEX TESTK800605ANA LATEX SLIDE TEST

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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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