510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K992163Substantially Equivalent

Abca Gas Isotope Ratio Mass Spectrometer Systems

Pdz-Europa, Ltd., Concord MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K992163 is the FDA 510(k) clearance record for ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS, a class I device, cleared for Pdz-Europa , Ltd. on under FDA product code DOP (Mass Spectrometer, Clinical Use). FDA records list one 510(k) clearance for Pdz-Europa , Ltd. As of , FDA records show no recalls naming K992163.

Clearance record

Decision date
Received
(18 days to decision)
Product code
DOP Mass Spectrometer, Clinical Use
Regulation
21 CFR 862.2860
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Pdz-Europa , Ltd. 325college Rd., Concord MA
510(k) summary
Summary
Third party review
No

Clearances, product code DOP

Trailing 12 months

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

FDA records show no clearances under product code DOP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DOP, 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