510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K850845Substantially Equivalent

0.85% Saline

Micro Media Laboratories, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850845 is the FDA 510(k) clearance record for 0.85% SALINE, a class I device, cleared for Micro Media Laboratories on under FDA product code PPM (General Purpose Reagent). FDA's definition for product code PPM reads: "A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for...". FDA records list 52 510(k) clearances for Micro Media Laboratories, from to . As of , FDA records show no recalls naming K850845.

Clearance record

Decision date
Received
(19 days to decision)
Product code
PPM General Purpose Reagent
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Applicant
Micro Media Laboratories 2775 Kurtz, San Diego CA
Third party review
No

Clearances, product code PPM

Trailing 12 months

FDA records hold no clearances under product code PPM in the trailing twelve months.

FDA records show no clearances under product code PPM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PPM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260