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FDA 510(k)

BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE

K-Number: K914202 · 1991-10-11

ApplicantBaxter Diagnostics, Inc.
Decision Date1991-10-11
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Diagnostics, Inc.. It received FDA 510(k) clearance on 1991-10-11 under 510(k) number K914202. 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 BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE?

BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE is a medical device that received FDA 510(k) clearance on 1991-10-11. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K914202.

When did BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE receive FDA 510(k) clearance?

BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE received FDA 510(k) clearance on 1991-10-11, under 510(k) number K914202.

Who is the listed applicant for BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE?

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

What is the FDA product code for BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE?

The FDA product code for BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE is JJQ.

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Other records listing Baxter Diagnostics, 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.

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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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