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FDA 510(k)

GEMINII GAMMA COUNTER

K-Number: K882194 · 1988-08-04

ApplicantLaboratory Technologies, Inc.
Decision Date1988-08-04
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GEMINII GAMMA COUNTER is the device name listed in this FDA 510(k) record. The listed applicant is Laboratory Technologies, Inc.. It received FDA 510(k) clearance on 1988-08-04 under 510(k) number K882194. 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 GEMINII GAMMA COUNTER?

GEMINII GAMMA COUNTER is a medical device that received FDA 510(k) clearance on 1988-08-04. The listed applicant is Laboratory Technologies, Inc.. The 510(k) number is K882194.

When did GEMINII GAMMA COUNTER receive FDA 510(k) clearance?

GEMINII GAMMA COUNTER received FDA 510(k) clearance on 1988-08-04, under 510(k) number K882194.

Who is the listed applicant for GEMINII GAMMA COUNTER?

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

What is the FDA product code for GEMINII GAMMA COUNTER?

The FDA product code for GEMINII GAMMA COUNTER is JJE.

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Other records listing Laboratory Technologies, 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.

K921536ACCULYTE CHEMILUMINESCENCE ANALYZERK900087GENESYS 6000 GAMMA COUNTERK851689GENESYS GAMMA COUNTER

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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