510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K062981Substantially Equivalent

I-Chroma Crp Test

Boditech Diagnostics, Inc., East Stroudsburg PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K062981 is the FDA 510(k) clearance record for I-CHROMA CRP TEST, a class II device, cleared for Boditech Diagnostics, Inc. on under FDA product code DCN (System, Test, C-Reactive Protein). FDA records list one 510(k) clearance for Boditech Diagnostics, Inc. As of , FDA records show no recalls naming K062981.

Clearance record

Decision date
Received
(287 days to decision)
Product code
DCN System, Test, C-Reactive Protein
Regulation
21 CFR 866.5270
Device class
Class II
Review panel
Immunology
Applicant
Boditech Diagnostics, Inc. 150 Cherry Ln. Rd., East Stroudsburg PA
510(k) summary
Statement
Third party review
No

Clearances, product code DCN

Trailing 12 months

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

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