FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SAF FIXATIVE
K Number: K803054
·
Decision Dec 22, 1980
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
0
Applicant Total
137
Review Days
20
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Basic Information
- Device Name
- SAF FIXATIVE
- K Number
- K803054
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Remel Co.
- Date Received
- December 2, 1980
- Decision Date
- December 22, 1980
- Product Code
- IGB
- Advisory Committee
- Pathology
- 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 |
|---|---|---|---|
| IGB | Solution, Formalin-Sodium Acetate | FDA class 1 | Pathology |
Other Clearances by Remel Co.
| K Number | Device Name | ||
|---|---|---|---|
| K013711 | BACTI-SWAB DRY | Nov 26, 2001 | Substantially Equivalent |
| K965150 | A.C.T. IV | Jan 22, 1997 | Substantially Equivalent |
| K965151 | A.C.T. III | Jan 22, 1997 | Substantially Equivalent |
| K965152 | A.C.T. II | Jan 22, 1997 | Substantially Equivalent |
| K965149 | A.C.T. I | Jan 22, 1997 | Substantially Equivalent |
| K960090 | CALCOFLUOR WHITE STAIN KIT | Mar 19, 1996 | Substantially Equivalent |
| K960095 | BACTIDROP CALCOFLUOR WHITE | Mar 19, 1996 | Substantially Equivalent |
| K955669 | REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK | Feb 23, 1996 | Substantially Equivalent |
| K941443 | SYNERGY QUAD | Sep 19, 1994 | Substantially Equivalent |
| K941444 | BHI AGAR WITH VANCOMYCIN | Sep 19, 1994 | Substantially Equivalent |