Phosphate Buffered Saline (Pbs), Phosphate Buffered Saline with Calcium, Magnesium, Glucose, Pyruvate and Phenol Red

by Sage Biopharma 510(k)

Active United States

510(k) K991378

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK991378	Date24 Sep 1999Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K991378
FDA Product Code: MQL

Device Class: Class II
Regulation: 21 CFR Part 884.6180
Advisory Committee: Obstetrics/Gynecology
FDA Decision: SESE Substantially Equivalent

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