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FDA 510(k)

STRATUS PHENOBARBITAL FLUOROMETRIC ENZ

K-Number: K830701 · 1983-05-13

ApplicantAmerican Dade
Decision Date1983-05-13
Product CodeLET
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

STRATUS PHENOBARBITAL FLUOROMETRIC ENZ is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1983-05-13 under 510(k) number K830701. The device is classified under product code LET. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATUS PHENOBARBITAL FLUOROMETRIC ENZ?

STRATUS PHENOBARBITAL FLUOROMETRIC ENZ is a medical device that received FDA 510(k) clearance on 1983-05-13. The listed applicant is American Dade. The 510(k) number is K830701.

When did STRATUS PHENOBARBITAL FLUOROMETRIC ENZ receive FDA 510(k) clearance?

STRATUS PHENOBARBITAL FLUOROMETRIC ENZ received FDA 510(k) clearance on 1983-05-13, under 510(k) number K830701.

Who is the listed applicant for STRATUS PHENOBARBITAL FLUOROMETRIC ENZ?

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 PHENOBARBITAL FLUOROMETRIC ENZ?

The FDA product code for STRATUS PHENOBARBITAL FLUOROMETRIC ENZ is LET.

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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: LET)

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.

K901537MODIFIED OPUS PHENOBARBITAL TEST SYSTEMPb Diagnostic Systems, Inc.K865000IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTSSclavo, Inc.K842592AMES TDA PHENOBARBITAL TESTMiles Laboratories, Inc.K821408PHENOBARBITAL FLUORESCENT IMMUNOAmerican Diagnostic Corp.K820188PHENOBARBITAL ASSAYSyva Co.K810994AMES TDA TM PHENOBARBITAL TESTMiles Laboratories, 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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