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FDA 510(k)

OPUS(R) PLUS ANALYZER

K-Number: K913295 · 1991-09-11

ApplicantPb Diagnostic Systems, Inc.
Decision Date1991-09-11
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OPUS(R) PLUS ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Pb Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1991-09-11 under 510(k) number K913295. 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 OPUS(R) PLUS ANALYZER?

OPUS(R) PLUS ANALYZER is a medical device that received FDA 510(k) clearance on 1991-09-11. The listed applicant is Pb Diagnostic Systems, Inc.. The 510(k) number is K913295.

When did OPUS(R) PLUS ANALYZER receive FDA 510(k) clearance?

OPUS(R) PLUS ANALYZER received FDA 510(k) clearance on 1991-09-11, under 510(k) number K913295.

Who is the listed applicant for OPUS(R) PLUS ANALYZER?

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

What is the FDA product code for OPUS(R) PLUS ANALYZER?

The FDA product code for OPUS(R) PLUS ANALYZER is JJQ.

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Other records listing Pb Diagnostic Systems, 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.

K940507OPUS FT4 TEST SYSTEMK934762OPUS PROCAINAMIDE TEST SYSTEMK933389OPUS CMV-GK934137OPUS(R) SEROLOGY CONTROLS, MODIFICATIONK935229OPUS DIGITOXINK934705OPUS NAPA

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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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