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FDA 510(k)

PERSONALLAB AUTOMATED MICROPLATE ANALYZER

K-Number: K971761 · 1997-07-22

ApplicantBiochem Immunosystems (U.S.), Inc.
Decision Date1997-07-22
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PERSONALLAB AUTOMATED MICROPLATE ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Biochem Immunosystems (U.S.), Inc.. It received FDA 510(k) clearance on 1997-07-22 under 510(k) number K971761. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERSONALLAB AUTOMATED MICROPLATE ANALYZER?

PERSONALLAB AUTOMATED MICROPLATE ANALYZER is a medical device that received FDA 510(k) clearance on 1997-07-22. The listed applicant is Biochem Immunosystems (U.S.), Inc.. The 510(k) number is K971761.

When did PERSONALLAB AUTOMATED MICROPLATE ANALYZER receive FDA 510(k) clearance?

PERSONALLAB AUTOMATED MICROPLATE ANALYZER received FDA 510(k) clearance on 1997-07-22, under 510(k) number K971761.

Who is the listed applicant for PERSONALLAB AUTOMATED MICROPLATE ANALYZER?

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

What is the FDA product code for PERSONALLAB AUTOMATED MICROPLATE ANALYZER?

The FDA product code for PERSONALLAB AUTOMATED MICROPLATE ANALYZER is JJE.

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Other records listing Biochem Immunosystems (U.S.), 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.

K960072SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AXK954065BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KITK955102BIODATA TESTOSTERONE MAIA KIT

Related Devices (Code: JJE)

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.

K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeHoriba, Ltd.K130276DIMENSION EXL WITH LM SYSTEMSiemens Healthcare Diagnostics, Inc.K113253ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K112999DIMENSION CLINICAL CHEMISTRY SYSTEMSiemens Healthcare DiagnosticsK110035INDIKOThermofisher Scientific OYK073370TC MATRIX CLINICAL CHEMISTRY ANALYZERTeco Diagnostics

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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