510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K892658Substantially Equivalent

Sdi Prepax Countapette Kit

Scientific Distributors, Inc., Norwood MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K892658 is the FDA 510(k) clearance record for SDI PREPAX COUNTAPETTE KIT, a class I device, cleared for Scientific Distributors, Inc. on under FDA product code JCG (Fluid, Diluting, Manual Cell). FDA records list 7 510(k) clearances for Scientific Distributors, Inc., from to . As of , FDA records show no recalls naming K892658.

Clearance record

Decision date
Received
(41 days to decision)
Product code
JCG Fluid, Diluting, Manual Cell
Regulation
21 CFR 864.8200
Device class
Class I
Review panel
Hematology
Applicant
Scientific Distributors, Inc. Bldg. 24 Endicott St., Norwood MA
Third party review
No

Clearances, product code JCG

Trailing 12 months

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

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