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FDA 510(k)

SENSITITRE AUTO ID PLATE AP80

K-Number: K890057 · 1989-06-09

ApplicantRadiometer America, Inc.
Decision Date1989-06-09
Product CodeLQM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SENSITITRE AUTO ID PLATE AP80 is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer America, Inc.. It received FDA 510(k) clearance on 1989-06-09 under 510(k) number K890057. The device is classified under product code LQM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENSITITRE AUTO ID PLATE AP80?

SENSITITRE AUTO ID PLATE AP80 is a medical device that received FDA 510(k) clearance on 1989-06-09. The listed applicant is Radiometer America, Inc.. The 510(k) number is K890057.

When did SENSITITRE AUTO ID PLATE AP80 receive FDA 510(k) clearance?

SENSITITRE AUTO ID PLATE AP80 received FDA 510(k) clearance on 1989-06-09, under 510(k) number K890057.

Who is the listed applicant for SENSITITRE AUTO ID PLATE AP80?

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

What is the FDA product code for SENSITITRE AUTO ID PLATE AP80?

The FDA product code for SENSITITRE AUTO ID PLATE AP80 is LQM.

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Other records listing Radiometer America, Inc. as applicant

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Related Devices (Code: LQM)

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.

K923313ROCHE OXI/FERM IIRoche Diagnostic Systems, Inc.K925915VITEK RAPID CALL-GRAM NEGATIV IDENT CARDBiomerieux Vitek, Inc.K912897SCEPTOR IDENTIFICATION SYSTEMBd Becton Dickinson Vacutainer Systems PreanalyticK911429VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIEDVitek Systems, Inc.K862642GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANELAmerican Micro ScanK851528PASCO GRAM NEGATIVE IDENTIFICATION SYSTEMPasco Laboratories, 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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