510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K833535Substantially Equivalent

Potassium Sodium Analysis Products

Shaban Mfg. Co., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833535 is the FDA 510(k) clearance record for POTASSIUM SODIUM ANALYSIS PRODUCTS, a class I device, cleared for Shaban Mfg. Co. on under FDA product code JJO (Flame Emission Photometer For Clinical Use). FDA records list 35 510(k) clearances for Shaban Mfg. Co., from to . As of , FDA records show no recalls naming K833535.

Clearance record

Decision date
Received
(93 days to decision)
Product code
JJO Flame Emission Photometer For Clinical Use
Regulation
21 CFR 862.2540
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Shaban Mfg. Co. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JJO

Trailing 12 months

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

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