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FDA 510(k)

CARBAMAZEPINE FLOURESCENT IMMUNOASSAY

K-Number: K821945 · 1982-07-16

ApplicantAmerican Diagnostic Corp.
Decision Date1982-07-16
Product CodeKLT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CARBAMAZEPINE FLOURESCENT IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is American Diagnostic Corp.. It received FDA 510(k) clearance on 1982-07-16 under 510(k) number K821945. The device is classified under product code KLT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARBAMAZEPINE FLOURESCENT IMMUNOASSAY?

CARBAMAZEPINE FLOURESCENT IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1982-07-16. The listed applicant is American Diagnostic Corp.. The 510(k) number is K821945.

When did CARBAMAZEPINE FLOURESCENT IMMUNOASSAY receive FDA 510(k) clearance?

CARBAMAZEPINE FLOURESCENT IMMUNOASSAY received FDA 510(k) clearance on 1982-07-16, under 510(k) number K821945.

Who is the listed applicant for CARBAMAZEPINE FLOURESCENT IMMUNOASSAY?

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

What is the FDA product code for CARBAMAZEPINE FLOURESCENT IMMUNOASSAY?

The FDA product code for CARBAMAZEPINE FLOURESCENT IMMUNOASSAY is KLT.

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Other records listing American Diagnostic 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.

K162589Adscope 658 Electronic StethoscopeK093495OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITSK060321ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BKK012304ADC 656 ELECTRONIC STETHOSCOPEK962655ANEROID AND MERCURIAL SPHYGMOMANOMETERSK940686ELECTRONIC THERMOMETERS

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Related Devices (Code: KLT)

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.

K123518ABBOTT CARBAMAZEPINE ASSAYMicrogenics CorporationK103627ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORSAbbott LaboratoriesK063131CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLSThermo Electron OYK042808ADVIA IMS CARBAMAZEPINE METHODBayer Healthcare, LLCK031902ONLINE TDM CARBAMAZEPINERoche Diagnostics Corp.K011648RANDOX CARBAMAZEPINERandox Laboratories, Ltd.

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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