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FDA 510(k)

BBL CAMPY POUCH

K-Number: K853534 · 1985-08-29

Decision Date1985-08-29
Product CodeKZJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BBL CAMPY POUCH is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1985-08-29 under 510(k) number K853534. The device is classified under product code KZJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BBL CAMPY POUCH?

BBL CAMPY POUCH is a medical device that received FDA 510(k) clearance on 1985-08-29. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K853534.

When did BBL CAMPY POUCH receive FDA 510(k) clearance?

BBL CAMPY POUCH received FDA 510(k) clearance on 1985-08-29, under 510(k) number K853534.

Who is the listed applicant for BBL CAMPY POUCH?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BBL CAMPY POUCH?

The FDA product code for BBL CAMPY POUCH is KZJ.

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.

Other records listing Bd Becton Dickinson Vacutainer Systems Preanalytic 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.

View all 632 devices →

Related Devices (Code: KZJ)

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.

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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