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FDA 510(k)

COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER

K-Number: K855149 · 1986-02-11

ApplicantHyperion, Inc.
Decision Date1986-02-11
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Hyperion, Inc.. It received FDA 510(k) clearance on 1986-02-11 under 510(k) number K855149. 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 COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER?

COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 1986-02-11. The listed applicant is Hyperion, Inc.. The 510(k) number is K855149.

When did COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER receive FDA 510(k) clearance?

COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER received FDA 510(k) clearance on 1986-02-11, under 510(k) number K855149.

Who is the listed applicant for COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER?

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

What is the FDA product code for COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER?

The FDA product code for COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER is JJQ.

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Other records listing Hyperion, 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.

K022800VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEMK013213HYPERION VISIQUANT ANA TEST KITK935983MICROREADER 4K913809HY-PREP SYSTEMK873138MICRO-READER IIK864060MICRO-READER

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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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