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FDA 510(k)

LASER-CAL

K-Number: K811063 · 1981-07-01

ApplicantDiagnostic Technology, Inc.
Decision Date1981-07-01
Product CodeKRX
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LASER-CAL is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Technology, Inc.. It received FDA 510(k) clearance on 1981-07-01 under 510(k) number K811063. The device is classified under product code KRX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LASER-CAL?

LASER-CAL is a medical device that received FDA 510(k) clearance on 1981-07-01. The listed applicant is Diagnostic Technology, Inc.. The 510(k) number is K811063.

When did LASER-CAL receive FDA 510(k) clearance?

LASER-CAL received FDA 510(k) clearance on 1981-07-01, under 510(k) number K811063.

Who is the listed applicant for LASER-CAL?

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

What is the FDA product code for LASER-CAL?

The FDA product code for LASER-CAL is KRX.

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Other records listing Diagnostic Technology, Inc. as applicant

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Related Devices (Code: KRX)

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.

K160585XN CALStreckK120747XN CAL PFStreckK120745XN CALStreckK111204CELL-DYN 22 PLUS CALIBRATORStreckK083200X-CALStreckK020469CAL-CHEX CD PLUSStreck Laboratories, 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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