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FDA 510(k)

PROTIME AUTOMATE TEST KIT

K-Number: K864392 · 1987-01-05

ApplicantAmerican Bioproducts Co.
Decision Date1987-01-05
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PROTIME AUTOMATE TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is American Bioproducts Co.. It received FDA 510(k) clearance on 1987-01-05 under 510(k) number K864392. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROTIME AUTOMATE TEST KIT?

PROTIME AUTOMATE TEST KIT is a medical device that received FDA 510(k) clearance on 1987-01-05. The listed applicant is American Bioproducts Co.. The 510(k) number is K864392.

When did PROTIME AUTOMATE TEST KIT receive FDA 510(k) clearance?

PROTIME AUTOMATE TEST KIT received FDA 510(k) clearance on 1987-01-05, under 510(k) number K864392.

Who is the listed applicant for PROTIME AUTOMATE TEST KIT?

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

What is the FDA product code for PROTIME AUTOMATE TEST KIT?

The FDA product code for PROTIME AUTOMATE TEST KIT is GJS.

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Other records listing American Bioproducts Co. 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.

K983460STAR AUTOMATED MULTI-PARAMETRIC ANALYZERK971519ASSERACHROM TPA TEST KITK964716STA LIATEST CONTROL [N]+[P] KITK964728STA-LIATEST D-DI TEST KITK964718STA D-DI CALIBRATOR KITK962675STA - LIATEST VWF TEST KIT

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Related Devices (Code: GJS)

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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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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