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FDA 510(k)

BASIC BIOPSY TRAY. DISPOSABLE, STERILE

K-Number: K964921 · 1997-01-22

ApplicantTrinity Laboratories, Inc.
Decision Date1997-01-22
Product CodeLRO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BASIC BIOPSY TRAY. DISPOSABLE, STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Trinity Laboratories, Inc.. It received FDA 510(k) clearance on 1997-01-22 under 510(k) number K964921. The device is classified under product code LRO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BASIC BIOPSY TRAY. DISPOSABLE, STERILE?

BASIC BIOPSY TRAY. DISPOSABLE, STERILE is a medical device that received FDA 510(k) clearance on 1997-01-22. The listed applicant is Trinity Laboratories, Inc.. The 510(k) number is K964921.

When did BASIC BIOPSY TRAY. DISPOSABLE, STERILE receive FDA 510(k) clearance?

BASIC BIOPSY TRAY. DISPOSABLE, STERILE received FDA 510(k) clearance on 1997-01-22, under 510(k) number K964921.

Who is the listed applicant for BASIC BIOPSY TRAY. DISPOSABLE, STERILE?

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

What is the FDA product code for BASIC BIOPSY TRAY. DISPOSABLE, STERILE?

The FDA product code for BASIC BIOPSY TRAY. DISPOSABLE, STERILE is LRO.

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Other records listing Trinity Laboratories, 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.

K981441HEART CATH TRAY, STERILE, DISPOSABLEK974238DENTAL TRAY, STERILE, DISPOSABLEK974286CIRCUMCISION TRAY, CAT. NO. 70340K972160CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TESTK970722EYE TRAYK965201O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE

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Related Devices (Code: LRO)

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.

K213481Medline General Surgery TrayMedline Industries, Inc.K212258Medline Cardiovascular Procedure KitMedline Industries, Inc.K041080SURGICAL DRAPE KIT - D.I.R.R.A. SRLD.I.R.R.A. S.R.L.K030721QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLEBallard Medical ProductsK023276AMSINO TRACHEOSTOMY CARE TRAYAmsino International, Inc.K980137WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAYWorldwide Medical Technologies, LLC

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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