Microtrak HSV 1/HSV 2 Culture Identi./Typing Test
FDA 510(k) K880157 · Syva Co.
510(k) numberK880157
Submission
- Device name
- Microtrak HSV 1/HSV 2 Culture Identi./Typing Test
- Applicant
- Syva Co.
Palo Alto, CA, US - Received
- January 13, 1988
- Decision date
- February 4, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GON – Antigen, Cf (Including Cf Control), Rubella
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3510
- Specialty
- Microbiology
Other 510(k)s with product code GON
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K894262 | Rubella Antigen and Control AntigenGON · Traditional | Microbix Biosystems, Inc. | 10/16/1989SE |
| K802939 | Herpes Simplex Type IGON · Traditional | Orion Diagnostica, Inc. | 12/31/1980SE |
| K802937 | Rubella Virus Antigens & ControlsGON · Traditional | Orion Diagnostica, Inc. | 12/31/1980SE |
| K780996 | Rubelisa Test KitGON · Traditional | Microbiological Assoc. | 11/22/1978SE |
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Questions and answers
When was Microtrak HSV 1/HSV 2 Culture Identi./Typing Test cleared by the FDA?
Microtrak HSV 1/HSV 2 Culture Identi./Typing Test (K880157) received a 510(k) decision of Substantially Equivalent on February 4, 1988, 22 days after the submission was received.
What is the product code of K880157?
The FDA product code is GON – Antigen, Cf (Including Cf Control), Rubella, a Class II (moderate risk) device regulated under 21 CFR 866.3510.