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FDA 510(k)

MONO ACU-SLIDE TEST

K-Number: K861211 · 1986-11-05

ApplicantCal-Tech Diagnostics, Inc.
Decision Date1986-11-05
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MONO ACU-SLIDE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Cal-Tech Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-11-05 under 510(k) number K861211. 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 MONO ACU-SLIDE TEST?

MONO ACU-SLIDE TEST is a medical device that received FDA 510(k) clearance on 1986-11-05. The listed applicant is Cal-Tech Diagnostics, Inc.. The 510(k) number is K861211.

When did MONO ACU-SLIDE TEST receive FDA 510(k) clearance?

MONO ACU-SLIDE TEST received FDA 510(k) clearance on 1986-11-05, under 510(k) number K861211.

Who is the listed applicant for MONO ACU-SLIDE TEST?

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

What is the FDA product code for MONO ACU-SLIDE TEST?

The FDA product code for MONO ACU-SLIDE TEST is JHJ.

Related Clinical Trials

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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Other records listing Cal-Tech 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.

K861212DIRECT ACU-SLIDE TESTK853247ACU-SLIDE-TEST

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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