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FDA 510(k)

KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER

K-Number: K864037 · 1986-11-13

ApplicantKera Corp.
Decision Date1986-11-13
Product CodeHJB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Kera Corp.. It received FDA 510(k) clearance on 1986-11-13 under 510(k) number K864037. The device is classified under product code HJB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER?

KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER is a medical device that received FDA 510(k) clearance on 1986-11-13. The listed applicant is Kera Corp.. The 510(k) number is K864037.

When did KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER receive FDA 510(k) clearance?

KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER received FDA 510(k) clearance on 1986-11-13, under 510(k) number K864037.

Who is the listed applicant for KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER?

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

What is the FDA product code for KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER?

The FDA product code for KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER is HJB.

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.

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Other records listing Kera Corp. 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.

K901009MODEL 2000 INTRAOPERATIVE CORNEASCOPEK871479VIDEOSCAN (TM)K850665CORNEASCOPE MODEL 1200

Related Devices (Code: HJB)

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.

K930444MARCO STANDARD KERATOMETERSMarco Ophthalmic, Inc.K924779BURTON KERATOMETER - MODLE 2040R.H. Burton Co.K864369LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNERHeidelberg InstrumentsK852424ACUFEX COMPARATIVE SURGICAL KERATOMETERAcufex Microsurgical, 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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