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FDA 510(k)

REAGENTS FOR ASTRA 8 AUTOMATED ANALYZER

K-Number: K801222 · 1980-06-26

ApplicantSimmler, Inc.
Decision Date1980-06-26
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENTS FOR ASTRA 8 AUTOMATED ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Simmler, Inc.. It received FDA 510(k) clearance on 1980-06-26 under 510(k) number K801222. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAGENTS FOR ASTRA 8 AUTOMATED ANALYZER?

REAGENTS FOR ASTRA 8 AUTOMATED ANALYZER is a medical device that received FDA 510(k) clearance on 1980-06-26. The listed applicant is Simmler, Inc.. The 510(k) number is K801222.

When did REAGENTS FOR ASTRA 8 AUTOMATED ANALYZER receive FDA 510(k) clearance?

REAGENTS FOR ASTRA 8 AUTOMATED ANALYZER received FDA 510(k) clearance on 1980-06-26, under 510(k) number K801222.

Who is the listed applicant for REAGENTS FOR ASTRA 8 AUTOMATED ANALYZER?

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

What is the FDA product code for REAGENTS FOR ASTRA 8 AUTOMATED ANALYZER?

The FDA product code for REAGENTS FOR ASTRA 8 AUTOMATED ANALYZER is JIX.

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Related Devices (Code: JIX)

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.

K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche DiagnosticsK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroupK123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare DiagnosticsK123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott LaboratoriesK122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, 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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