510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K984384Substantially Equivalent

6.8/7.3 Buffer Pack-Model A473-496, Wash Solution Pack-Model A73-497

Thermo Bioanalysis Corp., Holliston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984384 is the FDA 510(k) clearance record for 6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497, a class II device, cleared for Thermo Bioanalysis Corp. on under FDA product code CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph). FDA records list 2 510(k) clearances for Thermo Bioanalysis Corp., from to . As of , FDA records show no recalls naming K984384.

Clearance record

Decision date
Received
(15 days to decision)
Product code
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Regulation
21 CFR 862.1120
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Thermo Bioanalysis Corp. 333 Fiske St., Holliston MA
510(k) summary
Summary
Third party review
No

Clearances, product code CHL

Trailing 12 months
1 clearance under product code CHL in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CHL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260