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FDA 510(k)

ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55)

K-Number: K890698 · 1989-04-10

ApplicantAbbott Laboratories
Decision Date1989-04-10
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55) is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1989-04-10 under 510(k) number K890698. The device is classified under product code CKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55)?

ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55) is a medical device that received FDA 510(k) clearance on 1989-04-10. The listed applicant is Abbott Laboratories. The 510(k) number is K890698.

When did ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55) receive FDA 510(k) clearance?

ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55) received FDA 510(k) clearance on 1989-04-10, under 510(k) number K890698.

Who is the listed applicant for ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55)?

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

What is the FDA product code for ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55)?

The FDA product code for ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55) is CKA.

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Related Devices (Code: CKA)

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K120945HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ASTHitachi Chemical Diagnostics, Inc.K113382ACE ALT REAGENTAlfa WassermannK061020DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASEDade Behring, Inc.K020487CARESIDE ALTCareside, Inc.K980028ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, Inc.K973869TRACE REAGENT LINE FOR THE COBAS MIRATrace America, 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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