FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SULFURIC ACID 10%
K Number: K872186
·
Decision Jul 29, 1987
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
39
Applicant Total
137
Review Days
51
Basic Information
- Device Name
- SULFURIC ACID 10%
- K Number
- K872186
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- REMEL CO.
- Date Received
- June 8, 1987
- Decision Date
- July 29, 1987
- Product Code
- JTS
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| JTS | Stains, Microbiologic | FDA class 1 | Hematology |
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Other Clearances by REMEL CO.
| K Number | Device Name | ||
|---|---|---|---|
| K013711 | BACTI-SWAB DRY | Nov 26, 2001 | Substantially Equivalent |
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| K965152 | A.C.T. II | Jan 22, 1997 | Substantially Equivalent |
| K965150 | A.C.T. IV | Jan 22, 1997 | Substantially Equivalent |
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| 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 |