FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GELMAN LIPOPROTEIN FRS SET. P/N 51213
K Number: K791606
·
Decision Sep 17, 1979
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
25
Applicant Total
32
Review Days
28
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Basic Information
- Device Name
- GELMAN LIPOPROTEIN FRS SET. P/N 51213
- K Number
- K791606
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Gelman Sciences, Inc.
- Date Received
- August 20, 1979
- Decision Date
- September 17, 1979
- Product Code
- JHO
- 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 |
|---|---|---|---|
| JHO | Electrophoretic Separation, Lipoproteins | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JHO), ordered by most recent decision date.
SPIFE LIPPOROTEIN-12, MODEL 3344
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HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134
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·Clinical Chemistry
MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS
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MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123
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SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIPOPRINT SYSTEM, LDL SUBFRACTIONS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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 |