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FDA 510(k)

TB QUICK STAIN(TM) KIT

K-Number: K871117 · 1987-04-03

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1987-04-03
Product CodeICJ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TB QUICK STAIN(TM) KIT 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 1987-04-03 under 510(k) number K871117. The device is classified under product code ICJ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TB QUICK STAIN(TM) KIT?

TB QUICK STAIN(TM) KIT is a medical device that received FDA 510(k) clearance on 1987-04-03. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K871117.

When did TB QUICK STAIN(TM) KIT receive FDA 510(k) clearance?

TB QUICK STAIN(TM) KIT received FDA 510(k) clearance on 1987-04-03, under 510(k) number K871117.

Who is the listed applicant for TB QUICK STAIN(TM) KIT?

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 TB QUICK STAIN(TM) KIT?

The FDA product code for TB QUICK STAIN(TM) KIT is ICJ.

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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.

K003062BACTEC MGIT 960 SIR KITSK0035530.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGEK003461BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLEK002938B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16K001364BD DIRECTIGEN FLU A+BK000762MOXIFLOXACIN, 5 UG, BBL SENSI-DISC

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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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