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FDA 510(k)

BILIRUBINOMETER

K-Number: K811840 · 1981-07-15

ApplicantAdvanced Instruments, Inc.
Decision Date1981-07-15
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BILIRUBINOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Instruments, Inc.. It received FDA 510(k) clearance on 1981-07-15 under 510(k) number K811840. 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 BILIRUBINOMETER?

BILIRUBINOMETER is a medical device that received FDA 510(k) clearance on 1981-07-15. The listed applicant is Advanced Instruments, Inc.. The 510(k) number is K811840.

When did BILIRUBINOMETER receive FDA 510(k) clearance?

BILIRUBINOMETER received FDA 510(k) clearance on 1981-07-15, under 510(k) number K811840.

Who is the listed applicant for BILIRUBINOMETER?

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

What is the FDA product code for BILIRUBINOMETER?

The FDA product code for BILIRUBINOMETER is JJQ.

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Other records listing Advanced Instruments, 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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