FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEP-2 CELLS
K Number: K842834
·
Decision Aug 28, 1984
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
2
Applicant Total
35
Review Days
39
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Basic Information
- Device Name
- HEP-2 CELLS
- K Number
- K842834
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Bartels Immunodiagnostic Supplies, Inc.
- Date Received
- July 20, 1984
- Decision Date
- August 28, 1984
- Product Code
- KJR
- Advisory Committee
- Hematology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| KJR | Erythrosin B | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KJR), ordered by most recent decision date.
PMK PRIMARY MONKEY KIDNEY-CELLS
FDA 510(k)
FDA Class 1
·Hematology
FETAL CHECK
FDA 510(k)
FDA Class 1
·Hematology
Other Clearances by Bartels Immunodiagnostic Supplies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K864776 | A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS | Dec 31, 1986 | Substantially Equivalent |
| K861172 | ROTAVIRUS LATEX AGGLUTINATION ASSAY | Jul 1, 1986 | Substantially Equivalent |
| K860279 | CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT | May 13, 1986 | Substantially Equivalent |
| K855034 | AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT | Mar 11, 1986 | Substantially Equivalent |
| K842830 | IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF | Nov 26, 1985 | Substantially Equivalent |
| K852185 | RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT | Aug 19, 1985 | Substantially Equivalent |
| K844105 | FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY | Dec 6, 1984 | Substantially Equivalent |
| K842833 | PMK PRIMARY MONKEY KIDNEY-CELLS | Aug 28, 1984 | Substantially Equivalent |
| K842328 | AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN | Aug 3, 1984 | Substantially Equivalent |
| K842329 | AMER. HISTO-ID SYS PRIMARY IGG S7920-11 | Aug 2, 1984 | Substantially Equivalent |