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FDA 510(k)

GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK.

K-Number: K882450 · 1988-07-28

ApplicantDiamond Sensor Systems
Decision Date1988-07-28
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK. is the device name listed in this FDA 510(k) record. The listed applicant is Diamond Sensor Systems. It received FDA 510(k) clearance on 1988-07-28 under 510(k) number K882450. 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 GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK.?

GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK. is a medical device that received FDA 510(k) clearance on 1988-07-28. The listed applicant is Diamond Sensor Systems. The 510(k) number is K882450.

When did GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK. receive FDA 510(k) clearance?

GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK. received FDA 510(k) clearance on 1988-07-28, under 510(k) number K882450.

Who is the listed applicant for GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK.?

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

What is the FDA product code for GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK.?

The FDA product code for GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK. is JJE.

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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Other records listing Diamond Sensor Systems 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.

K873577GEM-STAT, GEM-PAK 2, GEM-CHECK, GEM-CRIT CHECKK871686GEM-CRIT CHECK

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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