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Fetal Check

by Alta Diagnostics Inc

510(k) K792546

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 8 Nov 2026. What this means

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK792546 Date18 Dec 1979ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 8 Nov 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
KJR
FDA applicant
Alta Diagnostics, Inc.
Device class
Class I
Regulation
21 CFR Part 864.1850
Advisory committee
Hematology
FDA decision
SESE Substantially Equivalent

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