FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACID FAST BACILLI STAIN CONTROL
K Number: K840515
·
Decision Mar 9, 1984
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
26
Applicant Total
28
Review Days
32
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ACID FAST BACILLI STAIN CONTROL
- K Number
- K840515
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Scientific Device Laboratory, Inc.
- Date Received
- February 6, 1984
- Decision Date
- March 9, 1984
- Product Code
- LJG
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LJG | Quality Control Slides | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LJG), ordered by most recent decision date.
MICROSPORIDIUM CONTROL SET
FDA 510(k)
FDA Class 1
·Microbiology
MICROSPORIDIUM CONTROL SLIDE
FDA 510(k)
FDA Class 1
·Microbiology
CRYPTOSPORIDIUM CONTROL SLIDE
FDA 510(k)
FDA Class 1
·Microbiology
GRAM STAIN CONTROL SLIDE
FDA 510(k)
FDA Class 1
·Microbiology
BION DIRECT IDENTIFICATION CONTROL SLIDE
FDA 510(k)
FDA Class 1
·Microbiology
HISTO-CHECK FUNGAL CONTROL SLIDES
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Scientific Device Laboratory, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K935316 | PARASAFE(R) FIXATIVE | Feb 17, 1994 | Substantially Equivalent |
| K924893 | MICROSPORIDIUM CONTROL SLIDE | Jan 15, 1993 | Substantially Equivalent |
| K911059 | TURBIDOMETRIC STANDARD | Jun 10, 1991 | Substantially Equivalent |
| K895848 | PRESSURE STEAM STERILIZERS | Dec 11, 1989 | Substantially Equivalent |
| K890670 | CRYPTOSPORIDIUM CONTROL SLIDE | Mar 16, 1989 | Substantially Equivalent |
| K890718 | GRAM STAIN CONTROL SLIDE | Mar 16, 1989 | Substantially Equivalent |
| K884069 | SNAP N' STAIN IODINE STAIN | Oct 25, 1988 | Substantially Equivalent |
| K884011 | SNAP N' STAIN IRON STAIN | Oct 6, 1988 | Substantially Equivalent |
| K883052 | METHENO-STAIN KIT | Aug 30, 1988 | Substantially Equivalent |
| K881598 | SDL TRICHROME STAIN | May 4, 1988 | Substantially Equivalent |