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FDA 510(k)

IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER

K-Number: K905215 · 1991-01-11

ApplicantCirrus Diagnostics, Inc.
Decision Date1991-01-11
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Cirrus Diagnostics, Inc.. It received FDA 510(k) clearance on 1991-01-11 under 510(k) number K905215. 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 IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER?

IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER is a medical device that received FDA 510(k) clearance on 1991-01-11. The listed applicant is Cirrus Diagnostics, Inc.. The 510(k) number is K905215.

When did IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER receive FDA 510(k) clearance?

IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER received FDA 510(k) clearance on 1991-01-11, under 510(k) number K905215.

Who is the listed applicant for IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER?

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

What is the FDA product code for IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER?

The FDA product code for IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER is JJQ.

Related Clinical Trials

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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Other records listing Cirrus 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.

K921704IMMULITE(R) FSHK920411IMMULITE HLHK914833IMMULITE DIGOXINK911796IMMULITE(TM) HCGK910677IMMULITE(TM) T-UPTAKEK910261IMMULITE(TM) TOTAL T4

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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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