FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
METHENO-STAIN KIT
K Number: K883052
·
Decision Aug 30, 1988
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
39
Applicant Total
28
Review Days
42
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Basic Information
- Device Name
- METHENO-STAIN KIT
- K Number
- K883052
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Scientific Device Laboratory, Inc.
- Date Received
- July 19, 1988
- Decision Date
- August 30, 1988
- 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 Scientific Device Laboratory, Inc.
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|---|---|---|---|
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| K911059 | TURBIDOMETRIC STANDARD | Jun 10, 1991 | Substantially Equivalent |
| K895848 | PRESSURE STEAM STERILIZERS | Dec 11, 1989 | Substantially Equivalent |
| K890670 | CRYPTOSPORIDIUM CONTROL SLIDE | Mar 16, 1989 | Substantially Equivalent |
| K890718 | GRAM STAIN CONTROL SLIDE | Mar 16, 1989 | Substantially Equivalent |
| K884069 | SNAP N' STAIN IODINE STAIN | Oct 25, 1988 | Substantially Equivalent |
| K884011 | SNAP N' STAIN IRON STAIN | Oct 6, 1988 | Substantially Equivalent |
| K881598 | SDL TRICHROME STAIN | May 4, 1988 | Substantially Equivalent |
| K840506 | HAEMOPHILUS INFLUENZAE TYPE B | Apr 4, 1984 | Substantially Equivalent |