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FDA 510(k)

BIO-PEN CALCULATOR

K-Number: K860205 · 1986-04-24

ApplicantOculab, Inc.
Decision Date1986-04-24
Product CodeLQB
DecisionSubstantially Equivalent

Device Summary

BIO-PEN CALCULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Oculab, Inc.. It received FDA 510(k) clearance on 1986-04-24 under 510(k) number K860205. The device is classified under product code LQB. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-PEN CALCULATOR?

BIO-PEN CALCULATOR is a medical device that received FDA 510(k) clearance on 1986-04-24. The listed applicant is Oculab, Inc.. The 510(k) number is K860205.

When did BIO-PEN CALCULATOR receive FDA 510(k) clearance?

BIO-PEN CALCULATOR received FDA 510(k) clearance on 1986-04-24, under 510(k) number K860205.

Who is the listed applicant for BIO-PEN CALCULATOR?

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

What is the FDA product code for BIO-PEN CALCULATOR?

The FDA product code for BIO-PEN CALCULATOR is LQB.

Related Clinical Trials

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Other records listing Oculab, 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.

K884619PACH-PEN CALCULATORK882750OCU-FILM TIP COVERK862016PACH-PEN SURGICAL DRAPEK860061OCULAB BIOMETRICPENK860062OCULAB PACHPENK852774OCULAB TONOPEN

View all 7 devices →

Related Devices (Code: LQB)

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.

K922590BIO-PEN SRK II CALCULATORBio-Rad

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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