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FDA 510(k)

COLOR VISION TESTERS

K-Number: K844365 · 1985-01-02

ApplicantLuneau Laboratories
Decision Date1985-01-02
Product CodeHIT
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

COLOR VISION TESTERS is the device name listed in this FDA 510(k) record. The listed applicant is Luneau Laboratories. It received FDA 510(k) clearance on 1985-01-02 under 510(k) number K844365. The device is classified under product code HIT. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLOR VISION TESTERS?

COLOR VISION TESTERS is a medical device that received FDA 510(k) clearance on 1985-01-02. The listed applicant is Luneau Laboratories. The 510(k) number is K844365.

When did COLOR VISION TESTERS receive FDA 510(k) clearance?

COLOR VISION TESTERS received FDA 510(k) clearance on 1985-01-02, under 510(k) number K844365.

Who is the listed applicant for COLOR VISION TESTERS?

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

What is the FDA product code for COLOR VISION TESTERS?

The FDA product code for COLOR VISION TESTERS is HIT.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Luneau Laboratories 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.

K850068LUNE AU CURETTESK844364SKIASCOPIC RACKSK844362OPHTHALMIC CHAIRK844363OPHTHALMIC STAND

Related Devices (Code: HIT)

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.

K903001SLIMCATH (TM)Gynopharma, Inc.K875026ANOMALOSCOPE PLATE TEST - 5 [APT-5]Lkc Technologies, Inc.K873908H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK.Richmond Products, Inc.K873911PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15Richmond Products, Inc.K844694TITMUS VISION TESTER IITitmus Optical, Inc.K832843OSCAR COLOUR VISION TESTERKeeler Instruments, 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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