510(k) K951821
- Device
- CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY
- Applicant
- LIGHT DIAGNOSTICS
- 510(k) number
- K951821
- Product code
- LIN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-06-07
- Date received
- 1995-04-20
- Regulation
- 866.3175
- Classification name
- Antisera, Conjugated Fluorescent, Cytomegalovirus
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DALE DEMBROW
- Address
- 28835 Single Oak Dr. Temecula CA US 92590 92590
FDA Registration Numbers#
- 1528450
- 9681582
Source Documents#
Other 510(k) Records For Product Code LIN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K081164 | D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT | Diagnostic Hybrids, Inc. | 2008-06-13 |
| K983762 | NUCLISENS CMV PP67 | Organon Teknika Corp. | 1999-09-15 |
| K991650 | CMV BRITE TURBO KIT | Biotest Diagnostics Corp. | 1999-07-12 |
| K951550 | CMV BRITE ANTIGENEMIA TEST KIT | Biotest Diagnostics Corp. | 1996-01-30 |
| K934798 | PATHODX CYTOMEGALOVIRUS | Diagnostic Products Corp. | 1994-03-25 |
| K921616 | CMV-VUE(TM) CMV ANTIGEN DETECTION KIT | Incstar Corp. | 1992-08-11 |
| K912592 | CMV-EA MAB TEST | Gull Laboratories, Inc. | 1991-12-04 |
| K905257 | OPUS CMV TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1991-04-17 |
| K904036 | BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN | Baxter Healthcare Corp | 1990-10-16 |
| K894002 | CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY | Baxter Healthcare Corp | 1989-08-10 |
| K893468 | CMV IGG ANTIBODY TEST (INDIRECT FLUORESCENT TEST) | Immuno Concepts, Inc. | 1989-07-14 |
| K893467 | CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST) | Immuno Concepts, Inc. | 1989-07-14 |
| K860279 | CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT | Bartels Immunodiagnostic Supplies, Inc. | 1986-05-13 |
| K843138 | CMV TEST | Microbiological Research Corp. | 1985-01-29 |
| K822606 | CYTOMEGALOVIRUS ANTOBODY IGG | Immulok, Inc. | 1982-11-01 |
Legacy Summary#
summary
FDA Review#
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