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FDA 510(k)

EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95

K-Number: K864553 · 1987-01-08

ApplicantEm Diagnostic Systems, Inc.
Decision Date1987-01-08
Product CodeKLT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95 is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1987-01-08 under 510(k) number K864553. 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 EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95?

EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95 is a medical device that received FDA 510(k) clearance on 1987-01-08. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K864553.

When did EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95 receive FDA 510(k) clearance?

EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95 received FDA 510(k) clearance on 1987-01-08, under 510(k) number K864553.

Who is the listed applicant for EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95?

The FDA 510(k) record lists Em Diagnostic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95?

The FDA product code for EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95 is KLT.

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Other records listing Em Diagnostic Systems, Inc. as applicant

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K935181ASPARTATE AMINOTRANSFERASE (AST) TESTK935180ALANINE AMINOTRANSFERASE (ALT) TESTK935178EMDS PHOSPHOROUS (PHOS) TESTK935179EMDS ALBUMIN (ALB) TESTK935175LACTATE DEHYDROGENASE (LD)K935174TOTAL PROTEIN TEST (TPRO)

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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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