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FDA 510(k)

STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS

K-Number: K853548 · 1985-09-18

ApplicantAmerican Dade
Decision Date1985-09-18
Product CodeLCM
DecisionSubstantially Equivalent

Device Summary

STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1985-09-18 under 510(k) number K853548. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS?

STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS is a medical device that received FDA 510(k) clearance on 1985-09-18. The listed applicant is American Dade. The 510(k) number is K853548.

When did STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS receive FDA 510(k) clearance?

STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS received FDA 510(k) clearance on 1985-09-18, under 510(k) number K853548.

Who is the listed applicant for STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS?

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

What is the FDA product code for STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS?

The FDA product code for STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS is LCM.

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Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

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Related Devices (Code: LCM)

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.

K212952Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in HairPsychemedics CorporationK203489SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis CorporationK181135Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis CorporationK163220Atellica CH Phencyclidine (Pcp)Siemens Healthcare Diagnostics, Inc.K131181OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINEOmega Laboratories, Inc.K122703RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTORBiophor Diagnostics, Inc.

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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