510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K870115Substantially Equivalent

Berthold Lb 2103,2104-Xt/pc/at,951g Gamma Counters

Berthold Analytical Instruments, Inc., Nashua NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870115 is the FDA 510(k) clearance record for BERTHOLD LB 2103,2104-XT/PC/AT,951G GAMMA COUNTERS, a class I device, cleared for Berthold Analytical Instruments, Inc. on under FDA product code JJJ (Counter (Beta, Gamma) For Clinical Use). FDA records list 2 510(k) clearances for Berthold Analytical Instruments, Inc., from to . As of , FDA records show no recalls naming K870115.

Clearance record

Decision date
Received
(78 days to decision)
Product code
JJJ Counter (Beta, Gamma) For Clinical Use
Regulation
21 CFR 862.2320
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Berthold Analytical Instruments, Inc. 28 Charron Ave., Nashua NH
Third party review
No

Clearances, product code JJJ

Trailing 12 months

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

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