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FDA 510(k)

MICROREADER 4

K-Number: K935983 · 1994-12-09

ApplicantHyperion, Inc.
Decision Date1994-12-09
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MICROREADER 4 is the device name listed in this FDA 510(k) record. The listed applicant is Hyperion, Inc.. It received FDA 510(k) clearance on 1994-12-09 under 510(k) number K935983. 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 MICROREADER 4?

MICROREADER 4 is a medical device that received FDA 510(k) clearance on 1994-12-09. The listed applicant is Hyperion, Inc.. The 510(k) number is K935983.

When did MICROREADER 4 receive FDA 510(k) clearance?

MICROREADER 4 received FDA 510(k) clearance on 1994-12-09, under 510(k) number K935983.

Who is the listed applicant for MICROREADER 4?

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 MICROREADER 4?

The FDA product code for MICROREADER 4 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 KITK913809HY-PREP SYSTEMK873138MICRO-READER IIK864060MICRO-READERK855149COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER

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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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