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FDA 510(k)

IDENTI-LOOPS

K-Number: K780720 · 1978-10-17

ApplicantBerkeley Bio-Medical, Inc.
Decision Date1978-10-17
Product CodeGAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IDENTI-LOOPS is the device name listed in this FDA 510(k) record. The listed applicant is Berkeley Bio-Medical, Inc.. It received FDA 510(k) clearance on 1978-10-17 under 510(k) number K780720. The device is classified under product code GAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IDENTI-LOOPS?

IDENTI-LOOPS is a medical device that received FDA 510(k) clearance on 1978-10-17. The listed applicant is Berkeley Bio-Medical, Inc.. The 510(k) number is K780720.

When did IDENTI-LOOPS receive FDA 510(k) clearance?

IDENTI-LOOPS received FDA 510(k) clearance on 1978-10-17, under 510(k) number K780720.

Who is the listed applicant for IDENTI-LOOPS?

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

What is the FDA product code for IDENTI-LOOPS?

The FDA product code for IDENTI-LOOPS is GAD.

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 Berkeley Bio-Medical, 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.

K780721IDENTI-CLAMPS

Related Devices (Code: GAD)

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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