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FDA 510(k)

STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO.

K-Number: K860140 · 1986-02-06

ApplicantAmerican Dade
Decision Date1986-02-06
Product CodeLAN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

STRATUS N-ACE (NAPA) 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 1986-02-06 under 510(k) number K860140. The device is classified under product code LAN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO.?

STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO. is a medical device that received FDA 510(k) clearance on 1986-02-06. The listed applicant is American Dade. The 510(k) number is K860140.

When did STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO. receive FDA 510(k) clearance?

STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO. received FDA 510(k) clearance on 1986-02-06, under 510(k) number K860140.

Who is the listed applicant for STRATUS N-ACE (NAPA) 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 N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO.?

The FDA product code for STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO. is LAN.

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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: LAN)

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.

K060738TDM N-ACETYLPROCAINAMIDERoche Diagnostics Corp.K032564DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111Dade Behring, Inc.K011620EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229Syva Co., Dade Behring, Inc.K983812NAPA EIA ASSAYDiagnostic Reagents, Inc.K971713N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEMBayer Corp.K955422AXSYM N-ACETYLPROCAINAMIDEAbbott Laboratories

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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