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Barbital Saline Buffer

by Bio/Data Corp.

510(k) K761170

Barbital Saline Buffer is a Class I device made by Bio/Data Corp., cleared under FDA 510(k) K761170 on 10 Jan 1977, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK761170 Date10 Jan 1977ClearedStatusActive

Official records

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  • Withdrawn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
JCE
Device class
Class I
Regulation
21 CFR Part 864.4010
Advisory committee
Pathology
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code JCE (Solution, Isotonic).

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