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FDA 510(k)

STRATUS FLUOROMETRIC ENZYME IMMUN0-

K-Number: K830301 · 1983-02-25

ApplicantAmerican Hospital Supply Corp.
Decision Date1983-02-25
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STRATUS FLUOROMETRIC ENZYME IMMUN0- is the device name listed in this FDA 510(k) record. The listed applicant is American Hospital Supply Corp.. It received FDA 510(k) clearance on 1983-02-25 under 510(k) number K830301. 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 STRATUS FLUOROMETRIC ENZYME IMMUN0-?

STRATUS FLUOROMETRIC ENZYME IMMUN0- is a medical device that received FDA 510(k) clearance on 1983-02-25. The listed applicant is American Hospital Supply Corp.. The 510(k) number is K830301.

When did STRATUS FLUOROMETRIC ENZYME IMMUN0- receive FDA 510(k) clearance?

STRATUS FLUOROMETRIC ENZYME IMMUN0- received FDA 510(k) clearance on 1983-02-25, under 510(k) number K830301.

Who is the listed applicant for STRATUS FLUOROMETRIC ENZYME IMMUN0-?

The FDA 510(k) record lists American Hospital Supply Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRATUS FLUOROMETRIC ENZYME IMMUN0-?

The FDA product code for STRATUS FLUOROMETRIC ENZYME IMMUN0- is JJE.

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Other records listing American Hospital Supply Corp. 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.

K854739AMERICAN STERILE SURGICAL ABSORBENT TOWELK854759AMERICAN STERILE MAYO STAND TRAYK832826AAP DOSIMETRY RELEASE OR BASIN SETSK830546DOSIMETRIC RELEASEK822990CONVERTORS PRIMARY WOUND DRESSING IIK830343CONTAINER W/PRIMING SOLUTION

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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

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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