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FDA 510(k)

PREGNANCY, SENSIDEX TUBE TEST

K-Number: K782063 · 1979-04-04

ApplicantOrtho Diagnostics, Inc.
Decision Date1979-04-04
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PREGNANCY, SENSIDEX TUBE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Diagnostics, Inc.. It received FDA 510(k) clearance on 1979-04-04 under 510(k) number K782063. 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, SENSIDEX TUBE TEST?

PREGNANCY, SENSIDEX TUBE TEST is a medical device that received FDA 510(k) clearance on 1979-04-04. The listed applicant is Ortho Diagnostics, Inc.. The 510(k) number is K782063.

When did PREGNANCY, SENSIDEX TUBE TEST receive FDA 510(k) clearance?

PREGNANCY, SENSIDEX TUBE TEST received FDA 510(k) clearance on 1979-04-04, under 510(k) number K782063.

Who is the listed applicant for PREGNANCY, SENSIDEX TUBE TEST?

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

What is the FDA product code for PREGNANCY, SENSIDEX TUBE TEST?

The FDA product code for PREGNANCY, SENSIDEX TUBE TEST is JHJ.

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Other records listing Ortho Diagnostics, 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.

K802404ORTHO BOVINE ALBUMIN SOLUTION 30% PROTEK801507ANTIGEN CONTROL CELLSK800357BI-LEVEL ASSAYED CARD. DRUG CONT., I,IIK800310ORTHO ANTISERA CONTROLK791791ORTHO ANTIBODY ENHANCEMENT SOLUTIONK791301ORTHO TSH RIA KIT

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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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