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FDA 510(k)

STAR AUTOMATED MULTI-PARAMETRIC ANALYZER

K-Number: K983460 · 1998-11-12

ApplicantAmerican Bioproducts Co.
Decision Date1998-11-12
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

STAR AUTOMATED MULTI-PARAMETRIC ANALYZER 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 1998-11-12 under 510(k) number K983460. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAR AUTOMATED MULTI-PARAMETRIC ANALYZER?

STAR AUTOMATED MULTI-PARAMETRIC ANALYZER is a medical device that received FDA 510(k) clearance on 1998-11-12. The listed applicant is American Bioproducts Co.. The 510(k) number is K983460.

When did STAR AUTOMATED MULTI-PARAMETRIC ANALYZER receive FDA 510(k) clearance?

STAR AUTOMATED MULTI-PARAMETRIC ANALYZER received FDA 510(k) clearance on 1998-11-12, under 510(k) number K983460.

Who is the listed applicant for STAR AUTOMATED MULTI-PARAMETRIC ANALYZER?

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 STAR AUTOMATED MULTI-PARAMETRIC ANALYZER?

The FDA product code for STAR AUTOMATED MULTI-PARAMETRIC ANALYZER is JPA.

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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.

K971519ASSERACHROM TPA TEST KITK964716STA LIATEST CONTROL [N]+[P] KITK964728STA-LIATEST D-DI TEST KITK964718STA D-DI CALIBRATOR KITK962675STA - LIATEST VWF TEST KITK962671STA-VWF CALIBRATOR KIT

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Related Devices (Code: JPA)

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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