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FDA PMA

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

PMA Number: P930036 · 2026-05-11

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2026-05-11
PMA NumberP930036
Product CodeLOK
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeIM

Device Summary

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2026-05-11. The device is classified under product code LOK. It was reviewed by the IM advisory panel.

Frequently Asked Questions

What is the KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS?

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS is a medical device that received FDA 510(k) clearance on 2026-05-11. The listed applicant is Siemens Healthcare Diagnostics, Inc..

When did KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS receive FDA 510(k) clearance?

The clearance date for KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS can be found in the official FDA records.

Who is the listed applicant for KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS?

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

What is the FDA product code for KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS?

The FDA product code for KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS is LOK.

Related Clinical Trials

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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