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FDA 510(k)

TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER

K-Number: K971111 · 1997-06-16

ApplicantTri-Tech, Inc.
Decision Date1997-06-16
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER is the device name listed in this FDA 510(k) record. The listed applicant is Tri-Tech, Inc.. It received FDA 510(k) clearance on 1997-06-16 under 510(k) number K971111. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER?

TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER is a medical device that received FDA 510(k) clearance on 1997-06-16. The listed applicant is Tri-Tech, Inc.. The 510(k) number is K971111.

When did TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER receive FDA 510(k) clearance?

TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER received FDA 510(k) clearance on 1997-06-16, under 510(k) number K971111.

Who is the listed applicant for TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER?

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

What is the FDA product code for TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER?

The FDA product code for TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER is JKA.

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Other records listing Tri-Tech, 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.

K952246TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KITK922343TRI-TECH INC. CUSTOM SEXUAL ASSAULT KITK922342TRI-TECH INC. CUSTOM BLOOD ALCOHOLK912140STAIRMASTER MODEL 6000 ERGOMETERK912056GRAVITRON UPPER BODY SYSTEM EXERCISERK9120574000 PT EXERCISE SYSTEM

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Related Devices (Code: JKA)

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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