FDA 510(k)
Substantially Equivalent
🇺🇸 United States
FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY
K Number: K844105
·
Decision Dec 6, 1984
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
35
Review Days
44
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Basic Information
- Device Name
- FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY
- K Number
- K844105
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Bartels Immunodiagnostic Supplies, Inc.
- Date Received
- October 23, 1984
- Decision Date
- December 6, 1984
- Advisory Committee
- Unknown
- Review Advisory Committee
- IM
- Third Party
- N
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| K842834 | HEP-2 CELLS | Aug 28, 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 |