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FDA 510(k)

STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO.

K-Number: K860141 · 1986-02-11

ApplicantAmerican Dade
Decision Date1986-02-11
Product CodeLAR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO. is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1986-02-11 under 510(k) number K860141. The device is classified under product code LAR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO.?

STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO. is a medical device that received FDA 510(k) clearance on 1986-02-11. The listed applicant is American Dade. The 510(k) number is K860141.

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

STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO. received FDA 510(k) clearance on 1986-02-11, under 510(k) number K860141.

Who is the listed applicant for STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO.?

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 IMMUNO.?

The FDA product code for STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO. is LAR.

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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

View all 149 devices →

Related Devices (Code: LAR)

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.

K060773ONLINE TDM PROCAINAMIDERoche Diagnostics Corp.K032573DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110Dade Behring, Inc.K010812EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229Syva Co., Dade Behring, Inc.K971716PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEMBayer Corp.K963306CEDIA N-ACETYLPROCAINAMIDE ASSAYBoehringer Mannheim Corp.K962099CEDIA PROCAINAMIDE ASSAYBoehringer Mannheim Corp.

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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