510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K840515Substantially Equivalent

Acid Fast Bacilli Stain Control

Scientific Device Laboratory, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840515 is the FDA 510(k) clearance record for ACID FAST BACILLI STAIN CONTROL, a class I device, cleared for Scientific Device Laboratory, Inc. on under FDA product code LJG (Quality Control Slides). FDA records list 28 510(k) clearances for Scientific Device Laboratory, Inc., from to . As of , FDA records show no recalls naming K840515.

Clearance record

Decision date
Received
(32 days to decision)
Product code
LJG Quality Control Slides
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Scientific Device Laboratory, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code LJG

Trailing 12 months

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

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