510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K083159Substantially Equivalent

Berichrom Heparin Lmw Calibrator, Berichrom Heparin Lmw Control 1, and Berichrom Heparin Lmw Control 2

Siemens Healthcare Diagnostics Inc., Newark DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083159 is the FDA 510(k) clearance record for BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2, a class II device, cleared for Siemens Healthcare Diagnostics on under FDA product code JPA (System, Multipurpose For In Vitro Coagulation Studies). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics, from to . As of , FDA records show no recalls naming K083159.

Clearance record

Decision date
Received
(91 days to decision)
Product code
JPA System, Multipurpose For In Vitro Coagulation Studies
Regulation
21 CFR 864.5425
Device class
Class II
Review panel
Hematology
Applicant
Siemens Healthcare Diagnostics 500 Gbc Dr., Newark DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JPA

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