510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K951122Substantially Equivalent

Capitol Urine Drug Screen Collection Kit

Harry A. Schlakman, Elizabeth NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K951122 is the FDA 510(k) clearance record for CAPITOL URINE DRUG SCREEN COLLECTION KIT, a class I device, cleared for Harry A. Schlakman on under FDA product code KDW (Container, Specimen Mailer And Storage, Temperature Controlled, Sterile). FDA records list 2 510(k) clearances for Harry A. Schlakman, from to . As of , FDA records show no recalls naming K951122.

Clearance record

Decision date
Received
(67 days to decision)
Product code
KDW Container, Specimen Mailer And Storage, Temperature Controlled, Sterile
Regulation
21 CFR 864.3250
Device class
Class I
Review panel
Pathology
Applicant
Harry A. Schlakman 304 Verona Ave., Elizabeth NJ
510(k) summary
Statement
Third party review
No

Clearances, product code KDW

Trailing 12 months

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

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