FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUTOPHOR 128
K Number: K810047
·
Decision Feb 5, 1981
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
25
Applicant Total
32
Review Days
24
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Basic Information
- Device Name
- AUTOPHOR 128
- K Number
- K810047
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7440
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Gelman Sciences, Inc.
- Date Received
- January 12, 1981
- Decision Date
- February 5, 1981
- Product Code
- JBD
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| JBD | System, Analysis, Electrophoretic Hemoglobin | FDA class 2 | Hematology |
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Other Clearances by Gelman Sciences, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K946190 | DRUG DISPENSING SPIKE | Mar 17, 1995 | Substantially Equivalent |
| K943127 | PHARMASSURE LARGE VOLUME TRANSFER FILTERS | Sep 29, 1994 | Substantially Equivalent |
| K941589 | SYRINGE FILTER DEVICES | Sep 6, 1994 | Substantially Equivalent |
| K941020 | DRUG RECONSTITUTION FILTER DEVICE | Aug 10, 1994 | Substantially Equivalent |
| K942275 | VIAL VENT FILTER | Jul 26, 1994 | Substantially Equivalent |
| K941032 | UNKNOWN | May 27, 1994 | Substantially Equivalent |
| K910821 | TRANSDUCER PROTECTOR | Aug 12, 1991 | Substantially Equivalent |
| K892387 | MODIFIED GELMAN ARTERIAL FILTER | Jun 22, 1989 | Substantially Equivalent |
| K884176 | CHROMATOGRAPHY KIT | Apr 4, 1989 | Substantially Equivalent |
| K884178 | DRUG CONTROL SET | Feb 17, 1989 | Substantially Equivalent |