FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPRAYFIX
K Number: K850916
·
Decision Mar 25, 1985
Classifications
1
FEI Numbers
258
Registration Numbers
258
Same Product Code
15
Applicant Total
30
Review Days
20
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
- SPRAYFIX
- K Number
- K850916
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Surgipath Medical Industries, Inc.
- Date Received
- March 5, 1985
- Decision Date
- March 25, 1985
- Product Code
- PPM
- Advisory Committee
- Pathology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| PPM | General Purpose Reagent | FDA class 1 | Pathology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PPM), ordered by most recent decision date.
TOMTEC GRAM STAINER DECOLORIZER
FDA 510(k)
FDA Class 1
·Pathology
POTASSIUM HYDROXIDE 10% W/V
FDA 510(k)
FDA Class 1
·Pathology
100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2
FDA 510(k)
FDA Class 1
·Pathology
0.85% SALINE
FDA 510(k)
FDA Class 1
·Pathology
TRANSPORT CULTURE MEDIUM
FDA 510(k)
FDA Class 1
·Pathology
DECOLORIZING FLUIC, ACID-ALCOHOL 3%
FDA 510(k)
FDA Class 1
·Pathology
Other Clearances by Surgipath Medical Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K883217 | SCHIFF REAGENT | Aug 5, 1988 | Substantially Equivalent |
| K881921 | C-E BRUSH | Jul 19, 1988 | Substantially Equivalent |
| K881922 | CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE | May 25, 1988 | Substantially Equivalent |
| K881659 | TISSUE SECTION ADHESIVE | Apr 21, 1988 | Substantially Equivalent |
| K863549 | REUSABLE/DISPOSABLE AUTOPSY KNIFE SET | Sep 30, 1986 | Substantially Equivalent |
| K863616 | KNIFE MAKER | Sep 25, 1986 | Substantially Equivalent |
| K863548 | ROTARY MICROTOME | Sep 19, 1986 | Substantially Equivalent |
| K863483 | CASSETTE EMBOSSEER | Sep 16, 1986 | Substantially Equivalent |
| K863145 | CERVICAL SCRAPERS | Aug 19, 1986 | Substantially Equivalent |
| K861270 | BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED. | Apr 11, 1986 | Substantially Equivalent |