Microtrak HSV 1 & 2 Direct Speciman
FDA 510(k) K841190 · Syva Co.
510(k) numberK841190
Submission
- Device name
- Microtrak HSV 1 & 2 Direct Speciman
- Applicant
- Syva Co.
Mchenry, IL, US - Received
- March 21, 1984
- Decision date
- January 18, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GQL – Antisera, Fluorescent, Herpesvirus Hominis 1,2
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3305
- Specialty
- Microbiology
Other 510(k)s with product code GQL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K091753 | Elvis HSV Id and D3 Typing Test SystemGQL · Traditional | Diagnostic Hybrids, Inc. | 08/28/2009SE |
| K081527 | Light Diagnostics HSV 1/2 Typing Dfa KitGQL · Traditional | Millipore Corporation | 04/01/2009SE |
| K984135 | The Aptus (Automated) Application of the HSV-1 Igg Elisa Test System. an Enzyme Linked…GQL · Traditional | Zeus Scientific, Inc. | 05/26/1999SE |
| K984120 | The Aptus(Automated) Application of the HSV-2 Igg Elisa Test System. an Enzyme Linked…GQL · Traditional | Zeus Scientific, Inc. | 05/26/1999SE |
| K905608 | Indirect Fluorescent Assay for Herpes Simplex 1GQL · Traditional | Stellar Bio Systems, Inc. | 11/07/1991SE |
| K904095 | Herpes Simplex Virus Tissue Culture Conf. TypingGQL · Traditional | California Integrated Diagnostics, Inc. | 02/01/1991SE |
| K904167 | Pathodx Herpes TypingGQL · Traditional | Diagnostic Products Corp. | 12/13/1990SE |
| K902662 | Bartels Herpes Simplex Vir Flu Mono Antibody TestGQL · Traditional | Baxter Healthcare Corp | 07/31/1990SE |
| K902661 | Bartels Herpes Simplex Vir Flu Mono Antib HSV-1&2GQL · Traditional | Baxter Healthcare Corp | 07/31/1990SE |
| K891782 | HSV-2 Elisa Test SystemGQL · Traditional | Zeus Scientific, Inc. | 06/20/1989SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K011878 | Emit (R) Tox Salicylic Assay, Model 7SO19UL, Emit (R) Tox Salicylic Acid Calibrators…DKJ · Traditional | 08/13/2001SE |
| K012257 | Emit II Plus Monoclonal Amphetamine/Methamphetamine Assay Model OSR9C229DKZ · Special | 08/03/2001SE |
| K011947 | Emit 2000 Valproic Acid Assay, Model OSR4G229ULLEG · Special | 07/02/2001SE |
| K011528 | Emit 2000 Phenobarbital Assay, Model OSR4D229DLZ · Special | 06/06/2001SE |
| K011347 | Emit 2000 Phenytoin Assay, Model 0SR4A229DIP · Special | 05/17/2001SE |
| K993981 | Syva Emit II Plus Propoxyphene Assay, Models 9G029UL/9G129ULJXN · Traditional | 02/01/2000SE |
| K993980 | Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409ULDML · Traditional | 02/01/2000SE |
| K993988 | Syva Emit II Plus Cocaine Metabolite Assay, Model 9H029ULDIO · Traditional | 01/27/2000SE |
| K993987 | Syva Emit II Plus Barbiturate Assay, Model 9D029UL/9D129ULKLT · Traditional | 01/27/2000SE |
| K993986 | Syva Emit II Plus Methaqualone Assay, Model 9Q029UL/9Q129ULKXS · Traditional | 01/27/2000SE |
Questions and answers
When was Microtrak HSV 1 & 2 Direct Speciman cleared by the FDA?
Microtrak HSV 1 & 2 Direct Speciman (K841190) received a 510(k) decision of Substantially Equivalent on January 18, 1985, 303 days after the submission was received.
What is the product code of K841190?
The FDA product code is GQL – Antisera, Fluorescent, Herpesvirus Hominis 1,2, a Class II (moderate risk) device regulated under 21 CFR 866.3305.