510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780946Substantially Equivalent

Royco Model 970 Hematology Data Analyzer

Hycel, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780946 is the FDA 510(k) clearance record for ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER, a class II device, cleared for Hycel, Inc. on under FDA product code JPJ (Red-Cell Indices, Calculated). FDA records list 19 510(k) clearances for Hycel, Inc., from to . As of , FDA records show no recalls naming K780946.

Clearance record

Decision date
Received
(48 days to decision)
Product code
JPJ Red-Cell Indices, Calculated
Regulation
21 CFR 864.5300
Device class
Class II
Review panel
Hematology
Applicant
Hycel, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JPJ

Trailing 12 months

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

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