FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRICE'S ACID-FAST STAIN
K Number: K870988
·
Decision Mar 30, 1987
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
39
Applicant Total
4
Review Days
19
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Basic Information
- Device Name
- PRICE'S ACID-FAST STAIN
- K Number
- K870988
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Devetec, Inc.
- Date Received
- March 11, 1987
- Decision Date
- March 30, 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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