FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MONO-POLY RESOLVING MEDIUM
K Number: K812947
·
Decision Mar 11, 1982
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
11
Applicant Total
57
Review Days
142
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MONO-POLY RESOLVING MEDIUM
- K Number
- K812947
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.8500
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Flow Laboratories, Inc.
- Date Received
- October 20, 1981
- Decision Date
- March 11, 1982
- Product Code
- JCF
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| JCF | Lymphocyte Separation Medium | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JCF), ordered by most recent decision date.
LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR
FDA 510(k)
FDA Class 1
·Hematology
LYMPHO SEP(TM)
FDA 510(k)
FDA Class 1
·Hematology
LEUCOPREP CELL SEPARATION TUBE
FDA 510(k)
FDA Class 1
·Hematology
L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA
FDA 510(k)
FDA Class 1
·Hematology
DYNABEADS HLA CELL PREP II ISOLATION PRODUCT
FDA 510(k)
FDA Class 1
·Hematology
LEUCOPREP BRAND TUBE
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 |