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FDA 510(k)

1570 - FETAL BLOOD SAMPLING KIT

K-Number: K891388 · 1989-03-28

ApplicantTransidyne General Corp.
Decision Date1989-03-28
Product CodeHGW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

1570 - FETAL BLOOD SAMPLING KIT is the device name listed in this FDA 510(k) record. The listed applicant is Transidyne General Corp.. It received FDA 510(k) clearance on 1989-03-28 under 510(k) number K891388. The device is classified under product code HGW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 1570 - FETAL BLOOD SAMPLING KIT?

1570 - FETAL BLOOD SAMPLING KIT is a medical device that received FDA 510(k) clearance on 1989-03-28. The listed applicant is Transidyne General Corp.. The 510(k) number is K891388.

When did 1570 - FETAL BLOOD SAMPLING KIT receive FDA 510(k) clearance?

1570 - FETAL BLOOD SAMPLING KIT received FDA 510(k) clearance on 1989-03-28, under 510(k) number K891388.

Who is the listed applicant for 1570 - FETAL BLOOD SAMPLING KIT?

The FDA 510(k) record lists Transidyne General Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 1570 - FETAL BLOOD SAMPLING KIT?

The FDA product code for 1570 - FETAL BLOOD SAMPLING KIT is HGW.

Related Clinical Trials

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Other records listing Transidyne General Corp. 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.

K961217BODILY FLUID DISPOSAL KITK955658LACERATION TRAYK950773PROPHYLAXIS PACKK950743ORAL PROCEDURE PACKK950449SURGICAL BURK950403SURGICAL SAW BLADES

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Related Devices (Code: HGW)

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.

K884685ROCKET FETAL BLOOD SAMPLING TRAYA & A Medical, Inc.K831459FETAL BLOOD SAMPLING KIT #1560Transidyne General Corp.K810028FETAL BLOOD SAMPLING KIT MODEL 1560Transidyne General Corp.

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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