510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K950822Substantially Equivalent

Solopak Pharmaceuticals Inc. Sterile Empty Vial

Solopak Laboratories, Inc., Elk Grove Village IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950822 is the FDA 510(k) clearance record for SOLOPAK PHARMACEUTICALS INC. STERILE EMPTY VIAL, cleared for Solopak Laboratories, Inc. on under FDA product code LDH. FDA records list one 510(k) clearance for Solopak Laboratories, Inc. As of , FDA records show no recalls naming K950822.

Clearance record

Decision date
Received
(28 days to decision)
Product code
LDH
Review panel
Unknown
Applicant
Solopak Laboratories, Inc. 1845 Tonne Rd., Elk Grove Village IL
510(k) summary
Summary
Third party review
No

Clearances, product code LDH

Trailing 12 months

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

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