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FDA 510(k)

ALT-30, 60 AND 100

K-Number: K861366 · 1986-06-25

ApplicantDimension Diagnostics
Decision Date1986-06-25
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALT-30, 60 AND 100 is the device name listed in this FDA 510(k) record. The listed applicant is Dimension Diagnostics. It received FDA 510(k) clearance on 1986-06-25 under 510(k) number K861366. 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 ALT-30, 60 AND 100?

ALT-30, 60 AND 100 is a medical device that received FDA 510(k) clearance on 1986-06-25. The listed applicant is Dimension Diagnostics. The 510(k) number is K861366.

When did ALT-30, 60 AND 100 receive FDA 510(k) clearance?

ALT-30, 60 AND 100 received FDA 510(k) clearance on 1986-06-25, under 510(k) number K861366.

Who is the listed applicant for ALT-30, 60 AND 100?

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

What is the FDA product code for ALT-30, 60 AND 100?

The FDA product code for ALT-30, 60 AND 100 is CKA.

Other records listing Dimension Diagnostics 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.

K863223DIMENSION-WBGK854967CRITIC - SF, ASSAYEDK853943CRITIC C LEVEL I & IIK852295UROL-GUANTK844848IMA-TROL IMMUNOASSAY CONTROLK844760UROL-QUAL

View all 8 devices →

Related Devices (Code: CKA)

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.

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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