510(k) K905608
- Device
- INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1
- Applicant
- STELLAR BIO SYSTEMS, INC.
- 510(k) number
- K905608
- Product code
- GQL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-11-07
- Date received
- 1990-12-14
- Regulation
- 866.3305
- Classification name
- Antisera, Fluorescent, Herpesvirus Hominis 1,2
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN M BREWER
- Address
- 9075 Guilford Rd. Columbia MD US 21046 21046
FDA Registration Numbers#
- 3003750284
- 2242436
- 2029372
- 3022178699
- 1528450
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GQL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K091753 | ELVIS HSV ID AND D3 TYPING TEST SYSTEM | Diagnostic Hybrids, Inc. | 2009-08-28 |
| K081527 | LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT | Millipore Corporation | 2009-04-01 |
| K984135 | THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR | Zeus Scientific, Inc. | 1999-05-26 |
| K984120 | THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH | Zeus Scientific, Inc. | 1999-05-26 |
| K904095 | HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING | California Integrated Diagnostics, Inc. | 1991-02-01 |
| K904167 | PATHODX HERPES TYPING | Diagnostic Products Corp. | 1990-12-13 |
| K902662 | BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST | Baxter Healthcare Corp | 1990-07-31 |
| K902661 | BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2 | Baxter Healthcare Corp | 1990-07-31 |
| K891782 | HSV-2 ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1989-06-20 |
| K891162 | HSV-1 ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1989-06-20 |
| K891382 | ORTHO HSV 1&2 DICHROMATIC TYPING REAGENT & SLIDES | Ortho Diagnostic Systems, Inc. | 1989-06-06 |
| K870814 | HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2 | Microscan Div. Baxter Healthcare Corp. | 1987-06-04 |
| K851635 | DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST | Diagnon Corp. | 1985-10-10 |
| K852360 | ORTHO DNA PROBE HSV CONFIRMATION TEST | Ortho Diagnostic Systems, Inc. | 1985-09-12 |
| K852125 | PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP | Kallestad Laboratories, Inc. | 1985-07-30 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases