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FDA 510(k)

BACTEC 13A MEDIUM (7H13)

K-Number: K863191 · 1986-09-15

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1986-09-15
Product CodeJSJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACTEC 13A MEDIUM (7H13) 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 1986-09-15 under 510(k) number K863191. The device is classified under product code JSJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BACTEC 13A MEDIUM (7H13)?

BACTEC 13A MEDIUM (7H13) is a medical device that received FDA 510(k) clearance on 1986-09-15. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K863191.

When did BACTEC 13A MEDIUM (7H13) receive FDA 510(k) clearance?

BACTEC 13A MEDIUM (7H13) received FDA 510(k) clearance on 1986-09-15, under 510(k) number K863191.

Who is the listed applicant for BACTEC 13A MEDIUM (7H13)?

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 BACTEC 13A MEDIUM (7H13)?

The FDA product code for BACTEC 13A MEDIUM (7H13) is JSJ.

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Related Devices (Code: JSJ)

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.

K882463POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421Lakewood Biochemical Co., Inc.K881544LITTMAN AGARAcumedia Manufacturers, Inc.K881561TERGITOL 7 BROTHAcumedia Manufacturers, Inc.K881526CHAPMAN STONE MEDIUMAcumedia Manufacturers, Inc.K881571YM BROTHAcumedia Manufacturers, Inc.K881578STREPTOSELAcumedia Manufacturers, Inc.

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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