510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K893768Substantially Equivalent

Modified Pk300 Automatic Eia Analyzer

Olympus Corp., Lake Success NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893768 is the FDA 510(k) clearance record for MODIFIED PK300 AUTOMATIC EIA ANALYZER, a class I device, cleared for Olympus Corp. on under FDA product code JJF (Analyzer, Chemistry, Micro, For Clinical Use). FDA records list 149 510(k) clearances for Olympus Corp., from to . As of , FDA records show no recalls naming K893768.

Clearance record

Decision date
Received
(88 days to decision)
Product code
JJF Analyzer, Chemistry, Micro, For Clinical Use
Regulation
21 CFR 862.2170
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Olympus Corp. 4 Nevada Dr., Lake Success NY
Third party review
No

Clearances, product code JJF

Trailing 12 months

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

FDA records show no clearances under product code JJF in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JJF, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260