FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PALL ULTIPOR VACUUM LINE BACTERIA FITLER
K Number: K812505
·
Decision Sep 16, 1981
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
37
Applicant Total
28
Review Days
15
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Basic Information
- Device Name
- PALL ULTIPOR VACUUM LINE BACTERIA FITLER
- K Number
- K812505
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Pall Biomedical Products Co.
- Date Received
- September 1, 1981
- Decision Date
- September 16, 1981
- Product Code
- JQC
- 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 |
|---|---|---|---|
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Pall Biomedical Products Co.
| K Number | Device Name | ||
|---|---|---|---|
| K954331 | PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) | Jan 9, 1997 | Substantially Equivalent |
| K960993 | PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST) | Apr 22, 1996 | Substantially Equivalent |
| K905794 | PALL 3N1 FILTER | Jun 13, 1991 | Substantially Equivalent |
| K902518 | LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE | Oct 16, 1990 | Substantially Equivalent |
| K884534 | PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER | Jan 24, 1989 | Substantially Equivalent |
| K875095 | PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE | Feb 29, 1988 | Substantially Equivalent |
| K875094 | ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE | Feb 29, 1988 | Substantially Equivalent |
| K873667 | PALL LEUKOCYTE REMOVAL FILTER, PLATELETS | Jan 6, 1988 | Substantially Equivalent |
| K873666 | PALL LEUKOCYTE REMOVAL FILTER, BLOOD | Jan 6, 1988 | Substantially Equivalent |
| K874405 | PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE | Dec 30, 1987 | Substantially Equivalent |