510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K882101Substantially Equivalent

Hemoglobin Screening Device

Portable Medical Laboratories, Inc., Solana Beach CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882101 is the FDA 510(k) clearance record for HEMOGLOBIN SCREENING DEVICE, a class I device, cleared for Portable Medical Laboratories, Inc. on under FDA product code KSL (Solution, Copper Sulfate For Specific Gravity Determinations). FDA records list 9 510(k) clearances for Portable Medical Laboratories, Inc., from to . As of , FDA records show no recalls naming K882101.

Clearance record

Decision date
Received
(51 days to decision)
Product code
KSL Solution, Copper Sulfate For Specific Gravity Determinations
Regulation
21 CFR 864.9320
Device class
Class I
Review panel
Hematology
Applicant
Portable Medical Laboratories, Inc. P.O. Box 667, Solana Beach CA
Third party review
No

Clearances, product code KSL

Trailing 12 months

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

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