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FDA 510(k)

BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540

K-Number: K022643 · 2002-11-05

ApplicantSwemed Lab International AB
Decision Date2002-11-05
Product CodeMQH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540 is the device name listed in this FDA 510(k) record. The listed applicant is Swemed Lab International AB. It received FDA 510(k) clearance on 2002-11-05 under 510(k) number K022643. The device is classified under product code MQH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540?

BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540 is a medical device that received FDA 510(k) clearance on 2002-11-05. The listed applicant is Swemed Lab International AB. The 510(k) number is K022643.

When did BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540 receive FDA 510(k) clearance?

BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540 received FDA 510(k) clearance on 2002-11-05, under 510(k) number K022643.

Who is the listed applicant for BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540?

The FDA 510(k) record lists Swemed Lab International AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540?

The FDA product code for BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540 is MQH.

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Other records listing Swemed Lab International AB 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.

K053208CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISION TRIAL TRANSFER CATHETER SETK991273SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLEK991700SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO

Related Devices (Code: MQH)

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.

K250838Denudation PipettesGuangzhou Pinzhi Medical Device Co., Ltd.K192146V-DENUPETVitromed GmbHK161275EZ-Tip Singles, EZ-Tip Vial of 20, EZ-GripResearch Instruments LimitedK152581LifeGlobal Micro TipsLife Global Group, LLCK151018Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction PipetteCook IncorporatedK102480INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HAJieying Laboratory, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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