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FDA 510(k)

APSARA CLINICAL DIAG. & INFO. SYS

K-Number: K823386 · 1983-02-09

ApplicantDatachem, Inc.
Decision Date1983-02-09
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

APSARA CLINICAL DIAG. & INFO. SYS is the device name listed in this FDA 510(k) record. The listed applicant is Datachem, Inc.. It received FDA 510(k) clearance on 1983-02-09 under 510(k) number K823386. 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 APSARA CLINICAL DIAG. & INFO. SYS?

APSARA CLINICAL DIAG. & INFO. SYS is a medical device that received FDA 510(k) clearance on 1983-02-09. The listed applicant is Datachem, Inc.. The 510(k) number is K823386.

When did APSARA CLINICAL DIAG. & INFO. SYS receive FDA 510(k) clearance?

APSARA CLINICAL DIAG. & INFO. SYS received FDA 510(k) clearance on 1983-02-09, under 510(k) number K823386.

Who is the listed applicant for APSARA CLINICAL DIAG. & INFO. SYS?

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

What is the FDA product code for APSARA CLINICAL DIAG. & INFO. SYS?

The FDA product code for APSARA CLINICAL DIAG. & INFO. SYS 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 Datachem, 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.

K900788MODIFIED APSARA CLINICAL DIAGNOSTIC ANALYZERK834534APSARA ANALYZERK813161FLO TEM II (BLOOD/FLUID WARMERK803249FLUID WARMER

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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