FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AD PERFECT
K Number: K940768
·
Decision Feb 17, 1995
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
0
Applicant Total
7
Review Days
364
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Basic Information
- Device Name
- AD PERFECT
- K Number
- K940768
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Chimera Research & Chemical, Inc.
- Date Received
- February 18, 1994
- Decision Date
- February 17, 1995
- Product Code
- IFT
- Advisory Committee
- Pathology
- 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 |
|---|---|---|---|
| IFT | Glutaraldehyde | FDA class 1 | Pathology |
Other Clearances by Chimera Research & Chemical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970087 | CR PERFECT | Mar 6, 1997 | Substantially Equivalent |
| K951877 | AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE | May 14, 1996 | Substantially Equivalent |
| K953393 | TOX PERFECT A TUBE | Oct 6, 1995 | Substantially Equivalent |
| K952501 | TOX PERFECT B TUBES AND REAGENTS | Aug 24, 1995 | Substantially Equivalent |
| K950142 | CR PERFECT | May 25, 1995 | Substantially Equivalent |
| K935408 | UA PERFECT | Jun 13, 1994 | Substantially Equivalent |