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FDA 510(k)

S-MONOVETTE EDTA K2-GEL

K-Number: K031359 · 2003-09-12

ApplicantSarstedt, Inc.
Decision Date2003-09-12
Product CodePJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

S-MONOVETTE EDTA K2-GEL is the device name listed in this FDA 510(k) record. The listed applicant is Sarstedt, Inc.. It received FDA 510(k) clearance on 2003-09-12 under 510(k) number K031359. The device is classified under product code PJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S-MONOVETTE EDTA K2-GEL?

S-MONOVETTE EDTA K2-GEL is a medical device that received FDA 510(k) clearance on 2003-09-12. The listed applicant is Sarstedt, Inc.. The 510(k) number is K031359.

When did S-MONOVETTE EDTA K2-GEL receive FDA 510(k) clearance?

S-MONOVETTE EDTA K2-GEL received FDA 510(k) clearance on 2003-09-12, under 510(k) number K031359.

Who is the listed applicant for S-MONOVETTE EDTA K2-GEL?

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

What is the FDA product code for S-MONOVETTE EDTA K2-GEL?

The FDA product code for S-MONOVETTE EDTA K2-GEL is PJE.

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Other records listing Sarstedt, 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.

K051019SAFETY NEEDLEK032150SAFETY-MULTIFLYK024237URINE MONOVETTE BORIC ACIDK003382SARSTEDT NEEDLE PROTECTORK913622HEMOPLUS

Related Devices (Code: PJE)

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.

K231469PAXgene® Blood DNA TubePreanalytix GmbHK042927VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBESGreiner Bio-One Vacuette North AmericaK014104VACUETTE EDTA K2 TUBESGreiner Vacuette North America, Inc.K012043VACUETTE EDTA K2 GEL TUBESGreiner Vacuette North America, Inc.K010328MULTIPLE (IZON DNA BLOOD COLLECTION KIT)Izon Business Products, Inc.K972075VACUTAINER BRAND PPT PLASMA PREPARATION TUBEBecton Dickinson Vacutainer Systems

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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