FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FORMALIN SOLUTION 10% NEUTRAL BUFFER
K Number: K840926
·
Decision Mar 12, 1984
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
14
Applicant Total
231
Review Days
10
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
- FORMALIN SOLUTION 10% NEUTRAL BUFFER
- K Number
- K840926
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Sigma Chemical Co.
- Date Received
- March 2, 1984
- Decision Date
- March 12, 1984
- Product Code
- IFP
- 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 |
|---|---|---|---|
| IFP | Formalin, Neutral Buffered | FDA class 1 | Pathology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IFP), ordered by most recent decision date.
CONSED FECAL CONCENTRATION SYSTEM
FDA 510(k)
FDA Class 1
·Pathology
DRY-FORM
FDA 510(k)
FDA Class 1
·Pathology
(MSI) PATH-SAVER
FDA 510(k)
FDA Class 1
·Pathology
NBF 10% NEUTRAL BUFFERED FORMALIN
FDA 510(k)
FDA Class 1
·Pathology
PREFILLED SPECIMEN JARS 10% NEUTRAL BUF-FORMALIN
FDA 510(k)
FDA Class 1
·Pathology
FORMALIN BUFFERED
FDA 510(k)
FDA Class 1
·Pathology
Other Clearances by Sigma Chemical Co.
| K Number | Device Name | ||
|---|---|---|---|
| K933694 | SIGMA GLUCOSE REAGENT | Nov 4, 1994 | Substantially Equivalent |
| K933678 | SIGMA CALCIUM REAGENT | Mar 11, 1994 | Substantially Equivalent |
| K933696 | SIGMA ELECTROLYTE REFERENCE REAGENT | Jan 3, 1994 | Substantially Equivalent |
| K933679 | SIGMA BUN REAGENT | Dec 17, 1993 | Substantially Equivalent |
| K933691 | SIGMA CO2 ALKALINE BUFFER REAGENT | Dec 17, 1993 | Substantially Equivalent |
| K933703 | SIGMA WASH CONCENTRATE SOLUTION | Dec 10, 1993 | Substantially Equivalent |
| K933692 | SIGMA CO2 ACID REAGENT | Dec 9, 1993 | Substantially Equivalent |
| K933695 | SIGMA ELECTROLYTE BUFFER | Oct 22, 1993 | Substantially Equivalent |
| K933697 | SIGMA CRE REAGENT | Oct 18, 1993 | Substantially Equivalent |
| K933693 | SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 | Oct 13, 1993 | Substantially Equivalent |