510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K811433Substantially Equivalent

Scrippsera Complement Control Sera

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

K811433 is the FDA 510(k) clearance record for SCRIPPSERA COMPLEMENT CONTROL SERA, a class I device, cleared for Scripps-Miles, Inc. on under FDA product code DHL (Protein, Complement, Antigen, Antiserum, Control). FDA records list 9 510(k) clearances for Scripps-Miles, Inc., from to . As of , FDA records show no recalls naming K811433.

Clearance record

Decision date
Received
(25 days to decision)
Product code
DHL Protein, Complement, Antigen, Antiserum, Control
Regulation
21 CFR 866.4100
Device class
Class I
Review panel
Immunology
Applicant
Scripps-Miles, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DHL

Trailing 12 months

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

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