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FDA 510(k)

PHARMASEAL GENETIC AMNIOCENTESIS TRAY

K-Number: K894031 · 1989-08-04

ApplicantBaxter Healthcare Corp
Decision Date1989-08-04
Product CodeHIO
Advisory CommitteeOB
DecisionUnknown

Device Summary

PHARMASEAL GENETIC AMNIOCENTESIS TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1989-08-04 under 510(k) number K894031. The device is classified under product code HIO. It was reviewed by the OB advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the PHARMASEAL GENETIC AMNIOCENTESIS TRAY?

PHARMASEAL GENETIC AMNIOCENTESIS TRAY is a medical device that received FDA 510(k) clearance on 1989-08-04. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K894031.

When did PHARMASEAL GENETIC AMNIOCENTESIS TRAY receive FDA 510(k) clearance?

PHARMASEAL GENETIC AMNIOCENTESIS TRAY received FDA 510(k) clearance on 1989-08-04, under 510(k) number K894031.

Who is the listed applicant for PHARMASEAL GENETIC AMNIOCENTESIS TRAY?

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

What is the FDA product code for PHARMASEAL GENETIC AMNIOCENTESIS TRAY?

The FDA product code for PHARMASEAL GENETIC AMNIOCENTESIS TRAY is HIO.

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Related Devices (Code: HIO)

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.

K960203G.E. STERILE AMNIOCENTESIS TRAYGE Medical SystemsK955679RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAYContour Fabricators of Florida, Inc.K914419AMNIOTEST(TM)Pro-Lab, Inc.K922960VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLECameo, Inc.K921738SONO-VU US(TM), MODIFICATIONE-Z-Em, Inc.K915863MEGA AMNIOCENTESIS KITMega Medical, Inc.

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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