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FDA 510(k)

BIO-PEN SRK II CALCULATOR

K-Number: K922590 · 1993-08-03

ApplicantBio-Rad
Decision Date1993-08-03
Product CodeLQB
DecisionSubstantially Equivalent

Device Summary

BIO-PEN SRK II CALCULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1993-08-03 under 510(k) number K922590. The device is classified under product code LQB. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-PEN SRK II CALCULATOR?

BIO-PEN SRK II CALCULATOR is a medical device that received FDA 510(k) clearance on 1993-08-03. The listed applicant is Bio-Rad. The 510(k) number is K922590.

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

BIO-PEN SRK II CALCULATOR received FDA 510(k) clearance on 1993-08-03, under 510(k) number K922590.

Who is the listed applicant for BIO-PEN SRK II CALCULATOR?

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

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

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

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Other records listing Bio-Rad 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.

K171061MRSASelect IIK122187VRESELECT CULTURE MEDIUMK103684VRESELECT CULTURE MEDIUMK093678PLATELIA ASPERGILLUS EIA MODEL 62793K100589MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENSK081362PLATELIA LYME IGM

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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.

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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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