CYLOMEGALOVIRUS DIRECT FLUORESCENT ANTI
FDA 510(k) clearance K820895 · decided 1982-05-03
Clearance details
- K-number
- K820895
- Device name
- CYLOMEGALOVIRUS DIRECT FLUORESCENT ANTI
- Applicant
- Bartels Immunodiagnostic Supplies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-03-30
- Decision date
- 1982-05-03
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- LIN
- Device class
- 2
- Regulation number
- 866.3175
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT (K081164) | Diagnostic Hybrids, Inc. | 2008-06-13 |
| NUCLISENS CMV PP67 (K983762) | Organon Teknika Corp. | 1999-09-15 |
| CMV BRITE TURBO KIT (K991650) | Biotest Diagnostics Corp. | 1999-07-12 |
| CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY (K951821) | Light Diagnostics | 1996-06-07 |
| CMV BRITE ANTIGENEMIA TEST KIT (K951550) | Biotest Diagnostics Corp. | 1996-01-30 |
| PATHODX CYTOMEGALOVIRUS (K934798) | Diagnostic Products Corp. | 1994-03-25 |
| CMV-VUE(TM) CMV ANTIGEN DETECTION KIT (K921616) | Incstar Corp. | 1992-08-11 |
| CMV-EA MAB TEST (K912592) | Gull Laboratories, Inc. | 1991-12-04 |
| OPUS CMV TEST SYSTEM (K905257) | Pb Diagnostic Systems, Inc. | 1991-04-17 |
| BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN (K904036) | Baxter Healthcare Corp | 1990-10-16 |
| CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY (K894002) | Baxter Healthcare Corp | 1989-08-10 |
| CMV IGG ANTIBODY TEST (INDIRECT FLUORESCENT TEST) (K893468) | Immuno Concepts, Inc. | 1989-07-14 |
Recalls involving this device
No recalls on record reference this clearance.