FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GELMAN ELECTROPHORESIS CONTROL
K Number: K811100
·
Decision May 1, 1981
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
32
Review Days
9
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Basic Information
- Device Name
- GELMAN ELECTROPHORESIS CONTROL
- K Number
- K811100
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Gelman Sciences, Inc.
- Date Received
- April 22, 1981
- Decision Date
- May 1, 1981
- Product Code
- JJY
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | FDA class 1 | Clinical Chemistry |
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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 |