Sera-Tek Mycoplasma Antibody Test
FDA 510(k) K832132 · Miles Laboratories, Inc.
510(k) numberK832132
Submission
- Device name
- Sera-Tek Mycoplasma Antibody Test
- Applicant
- Miles Laboratories, Inc.
Walker, MI, US - Received
- July 1, 1983
- Decision date
- September 20, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GSB – Antigens, Cf, All, Mycoplasma Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3375
- Specialty
- Microbiology
Other 510(k)s with product code GSB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K852933 | Mycoplasma SPP Serological ReagentsGSB · Traditional | Microbix Biosystems, Inc. | 08/01/1985SE |
| K843664 | Mycoplasma PneumoniaeGSB · Traditional | Institute Virion , Ltd. | 10/25/1984SE |
| K834338 | Mycoplasma Pneumoniae CF AntigenGSB · Traditional | Hillcrest Biologicals | 02/27/1984SE |
| K802934 | Mycoplasma Pneumoniae Antigen & ControlGSB · Traditional | Orion Diagnostica, Inc. | 12/31/1980SE |
More from Orion Diagnostica, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K880605 | Labeling Change for Cutter Pureflo Plus IV FilterFPB · Traditional | 05/26/1988SE |
| K874909 | Micro-Bumintest Reagent TabletsJIR · Traditional | 04/28/1988SE |
| K875079 | Modified Seralyzer Alt/Sgpt Reag. Strips & ModuleCKA · Traditional | 04/05/1988SE |
| K871835 | Glucometer QC Blood Meter, Ames Gluco System PrintCGA · Traditional | 12/22/1987SE |
| K872120 | Seralyzer III Blood Chemistry AnalyzerJJF · Traditional | 10/28/1987SE |
| K873304 | Clinitek Auto 2000 Reagent Cassette (Leukocytes)LJX · Traditional | 09/11/1987SE |
| K872634 | Cutter Pureflo Plus IV FilterFPB · Traditional | 08/04/1987SE |
| K870214 | Modified Saltex Reagent StripsCHK · Traditional | 06/29/1987SE |
| K870752 | Seralyzer Ldh/Total Bilirubin/Triglycerides StripsCFJ · Traditional | 04/14/1987SE |
| K865053 | Sera-Tek Microsomal Antibody TestJZO · Traditional | 02/18/1987SE |
Questions and answers
When was Sera-Tek Mycoplasma Antibody Test cleared by the FDA?
Sera-Tek Mycoplasma Antibody Test (K832132) received a 510(k) decision of Substantially Equivalent on September 20, 1983, 81 days after the submission was received.
What is the product code of K832132?
The FDA product code is GSB – Antigens, Cf, All, Mycoplasma Spp., a Class I (low risk) device regulated under 21 CFR 866.3375.