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FDA 510(k)

ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS

K-Number: K102699 · 2011-04-01

ApplicantAbbott Laboratories
Decision Date2011-04-01
Product CodeLCD
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2011-04-01 under 510(k) number K102699. The device is classified under product code LCD. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS?

ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS is a medical device that received FDA 510(k) clearance on 2011-04-01. The listed applicant is Abbott Laboratories. The 510(k) number is K102699.

When did ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS receive FDA 510(k) clearance?

ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS received FDA 510(k) clearance on 2011-04-01, under 510(k) number K102699.

Who is the listed applicant for ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS?

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 ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS?

The FDA product code for ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS is LCD.

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Other records listing Abbott Laboratories as applicant

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Related Devices (Code: LCD)

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.

K243500ARCHITECT iGentamicinAbbott LaboratoriesK060709MULTIGENT GENTAMICINSeradyn, Inc.K042479VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHEOrtho-Clinical Diagnostics, Inc.K020704ROCHE ONLINE GENTAMICINRoche Diagnostics Corp.K012978RANDOX GENTAMICINRandox Laboratories, Ltd.K012311IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)Diagnostic Products Corp.

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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