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FDA 510(k)

BIOCALEX 6/9

K-Number: K941532 · 1994-08-02

ApplicantBio-Probe, Inc.
Decision Date1994-08-02
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOCALEX 6/9 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Probe, Inc.. It received FDA 510(k) clearance on 1994-08-02 under 510(k) number K941532. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOCALEX 6/9?

BIOCALEX 6/9 is a medical device that received FDA 510(k) clearance on 1994-08-02. The listed applicant is Bio-Probe, Inc.. The 510(k) number is K941532.

When did BIOCALEX 6/9 receive FDA 510(k) clearance?

BIOCALEX 6/9 received FDA 510(k) clearance on 1994-08-02, under 510(k) number K941532.

Who is the listed applicant for BIOCALEX 6/9?

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

What is the FDA product code for BIOCALEX 6/9?

The FDA product code for BIOCALEX 6/9 is EJK.

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 Bio-Probe, 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.

K922985CLEAN UP

Related Devices (Code: EJK)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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