FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SMAC SYSTEM
K Number: K770508
·
Decision May 9, 1977
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
6
Applicant Total
5
Review Days
53
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Basic Information
- Device Name
- SMAC SYSTEM
- K Number
- K770508
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Mid Tech, Inc.
- Date Received
- March 17, 1977
- Decision Date
- May 9, 1977
- Product Code
- JCC
- Advisory Committee
- Pathology
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JCC | Ph Buffer | FDA class 1 | Pathology |
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Other Clearances by Mid Tech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K810951 | REAGENTS FOR QUANT. ENZYMATIC DETER.-TR. | Apr 23, 1981 | Substantially Equivalent |
| K791869 | GLUCOSE OXIDASE (FRINDER) KIT | Oct 1, 1979 | Substantially Equivalent |
| K791313 | ARS, CHEMISTRY | Aug 16, 1979 | Substantially Equivalent |
| K771033 | SMAC SYS., SUPPLEMENTAL PRODUCTS FOR | Aug 4, 1977 | Substantially Equivalent |