FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PSEUDO-PALETTE TM
K Number: K790992
·
Decision Jun 22, 1979
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
5
Applicant Total
2
Review Days
24
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Basic Information
- Device Name
- PSEUDO-PALETTE TM
- K Number
- K790992
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Micro-Palettes, Inc.
- Date Received
- May 29, 1979
- Decision Date
- June 22, 1979
- Product Code
- JSW
- Advisory Committee
- Microbiology
- 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 |
|---|---|---|---|
| JSW | Kit, Identification, Glucose Nonfermenter | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JSW), ordered by most recent decision date.
RAPID NFT, MODIFICATION
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RAPID NF SYSTEM
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·Microbiology
NON-FERMENTER SYSTEM
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PANEL, GNF, MICRO-ID
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Other Clearances by Micro-Palettes, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K790991 | YEAST-PALETTE TM | Jun 22, 1979 | Substantially Equivalent |