FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PBS FOR FA (46-991-49)
K Number: K781391
·
Decision Aug 21, 1978
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
16
Applicant Total
57
Review Days
11
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Basic Information
- Device Name
- PBS FOR FA (46-991-49)
- K Number
- K781391
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2875
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Flow Laboratories, Inc.
- Date Received
- August 10, 1978
- Decision Date
- August 21, 1978
- Product Code
- KIP
- Advisory Committee
- Hematology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| KIP | Formulations, Balanced Salt Solutions | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KIP), ordered by most recent decision date.
KREBS-RINGER BICARBONATE BUFFER PRODUCT NO. K4002
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EARLE'S BALANCED SALTS (EBSS) HYBRI-MAX #E9509
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(D-PBS) MODIFIED HYBRI-MAX PRODUCT NO. D7030
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HANKS' BALANCED SALTS (HBSS) NO. H1387
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DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2
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FDA Class 1
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HEPES BUFFER IM IN NORMAL SALINE
FDA 510(k)
FDA Class 1
·Hematology
Other Clearances by Flow Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861897 | UNISKAN II | Jul 1, 1986 | Substantially Equivalent |
| K862066 | TITERTEK MICROPLATE WASHER S-12 | Jun 5, 1986 | Substantially Equivalent |
| K861823 | GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN) | May 20, 1986 | Substantially Equivalent |
| K861824 | GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) | May 20, 1986 | Substantially Equivalent |
| K861791 | PENICILLIN-STREPTOMYCIN-FUNGIZONE | May 20, 1986 | Substantially Equivalent |
| K860752 | GOAT SERUM (29-391-54) | Mar 10, 1986 | Substantially Equivalent |
| K860762 | GAMMA-FREE HORSE SERUM | Mar 10, 1986 | Substantially Equivalent |
| K850908 | TITERTEK MICROITTRATION EQUIP. HANDIWASH 110 12CHA | Mar 25, 1985 | Substantially Equivalent |
| K844418 | TITERTEK MULTISKAN MCC | Mar 21, 1985 | Substantially Equivalent |
| K844419 | TITERTEK MULTISKAN MSS/340 | Mar 21, 1985 | Substantially Equivalent |