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FDA 510(k)

PREGNA-TEC

K-Number: K832527 · 1983-09-12

ApplicantMedilab Corp.
Decision Date1983-09-12
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PREGNA-TEC is the device name listed in this FDA 510(k) record. The listed applicant is Medilab Corp.. It received FDA 510(k) clearance on 1983-09-12 under 510(k) number K832527. 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 PREGNA-TEC?

PREGNA-TEC is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Medilab Corp.. The 510(k) number is K832527.

When did PREGNA-TEC receive FDA 510(k) clearance?

PREGNA-TEC received FDA 510(k) clearance on 1983-09-12, under 510(k) number K832527.

Who is the listed applicant for PREGNA-TEC?

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

What is the FDA product code for PREGNA-TEC?

The FDA product code for PREGNA-TEC is JHJ.

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Other records listing Medilab Corp. 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.

K841862IMMU-TECK841863MONO-TECK840290MCS TOTAL PROTEIN REAGENTK840291MCS ALBUMIN REAGENTK840289LYSE-TECK832918PREGNA-TEC

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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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