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FDA 510(k)

TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE

K-Number: K911438 · 1991-05-23

ApplicantBio-Tek Instruments, Inc.
Decision Date1991-05-23
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Tek Instruments, Inc.. It received FDA 510(k) clearance on 1991-05-23 under 510(k) number K911438. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE?

TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE is a medical device that received FDA 510(k) clearance on 1991-05-23. The listed applicant is Bio-Tek Instruments, Inc.. The 510(k) number is K911438.

When did TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE receive FDA 510(k) clearance?

TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE received FDA 510(k) clearance on 1991-05-23, under 510(k) number K911438.

Who is the listed applicant for TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE?

The FDA 510(k) record lists Bio-Tek Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE?

The FDA product code for TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE is JJQ.

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Other records listing Bio-Tek Instruments, Inc. as applicant

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K973609IDA-4 AND IPT-MCK971273INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EFK961862MODELS IDA-2 PLUS AND IPT-1K954391MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTERK953710ELX808 AUTOMATED MICROPLATE READERSK953572ELX800UV

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Related Devices (Code: JJQ)

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.

K013371UBIT-IR300 INFRARED SPECTROMETRY SYSTEMOtsuka Pharmaceutical Co., Ltd.K980120DIGENE DML 2000 MICROPLATE LUMINOMETERDigene Corp.K973938ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READERSfri, Inc.K974762STAT TRACKSAwareness Technology, Inc.K962113ANTHOS PHACTS VERSION MICROPLATE READERColumbia Bioscience, Inc.K961183CBI 7520 READERColumbia Bioscience, 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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