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FDA 510(k)

PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM

K-Number: K851528 · 1985-07-15

ApplicantPasco Laboratories, Inc.
Decision Date1985-07-15
Product CodeLQM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pasco Laboratories, Inc.. It received FDA 510(k) clearance on 1985-07-15 under 510(k) number K851528. 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 PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM?

PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM is a medical device that received FDA 510(k) clearance on 1985-07-15. The listed applicant is Pasco Laboratories, Inc.. The 510(k) number is K851528.

When did PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM receive FDA 510(k) clearance?

PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM received FDA 510(k) clearance on 1985-07-15, under 510(k) number K851528.

Who is the listed applicant for PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM?

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

What is the FDA product code for PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM?

The FDA product code for PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM is LQM.

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Other records listing Pasco Laboratories, Inc. 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.

K042331PASCO MIC AND MIC/ID PANELSK041776PASCO MIC AND MIC/ID PANELSK041214PASCO MIC AND MIC/ID PANELSK033119PASCO MIC AND MIC/ID PANELSK031727PASCO MIC AND MIC/ID PANELS, GEMIFLOXACINK031205PASCO MIC AND MIC/ID PANELS

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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.K890057SENSITITRE AUTO ID PLATE AP80Radiometer America, Inc.K862642GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANELAmerican Micro Scan

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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