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FDA 510(k)

MICRO-READER II

K-Number: K873138 · 1987-09-14

ApplicantHyperion, Inc.
Decision Date1987-09-14
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MICRO-READER II is the device name listed in this FDA 510(k) record. The listed applicant is Hyperion, Inc.. It received FDA 510(k) clearance on 1987-09-14 under 510(k) number K873138. 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 MICRO-READER II?

MICRO-READER II is a medical device that received FDA 510(k) clearance on 1987-09-14. The listed applicant is Hyperion, Inc.. The 510(k) number is K873138.

When did MICRO-READER II receive FDA 510(k) clearance?

MICRO-READER II received FDA 510(k) clearance on 1987-09-14, under 510(k) number K873138.

Who is the listed applicant for MICRO-READER II?

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 MICRO-READER II?

The FDA product code for MICRO-READER II 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 SYSTEMK864060MICRO-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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