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FDA 510(k)

AUTOMATIC BIOCHEMICAL ANALYZER

K-Number: K810063 · 1981-01-26

ApplicantAcculab
Decision Date1981-01-26
Product CodeJQP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTOMATIC BIOCHEMICAL ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Acculab. It received FDA 510(k) clearance on 1981-01-26 under 510(k) number K810063. The device is classified under product code JQP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOMATIC BIOCHEMICAL ANALYZER?

AUTOMATIC BIOCHEMICAL ANALYZER is a medical device that received FDA 510(k) clearance on 1981-01-26. The listed applicant is Acculab. The 510(k) number is K810063.

When did AUTOMATIC BIOCHEMICAL ANALYZER receive FDA 510(k) clearance?

AUTOMATIC BIOCHEMICAL ANALYZER received FDA 510(k) clearance on 1981-01-26, under 510(k) number K810063.

Who is the listed applicant for AUTOMATIC BIOCHEMICAL ANALYZER?

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

What is the FDA product code for AUTOMATIC BIOCHEMICAL ANALYZER?

The FDA product code for AUTOMATIC BIOCHEMICAL ANALYZER is JQP.

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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Related Devices (Code: JQP)

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.

K113007BIONIME DIABETES MANAGEMENT SYSTEM VI.0Bionime CorporationK983468FASTTAKE ADAPTER, MODEL # P/N 020-072-01Selfcare, Inc.K964460THE ROBOLITEShai Syg Motion and Innovations, Ltd.K953652PRENVAL IBase Ten Systems, Inc.K934111MR7000 WITH TIME MANAGER SOFTWARE (TMS)Dynatech Laboratories, Inc.K923316EXPRESSO CARTRIDGEBio-Rad Laboratories, 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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