Kallestad RSV Microplate Eia
FDA 510(k) K924289 · Bio-Rad Laboratories, Inc.
510(k) numberK924289
Submission
- Device name
- Kallestad RSV Microplate Eia
- Applicant
- Bio-Rad Laboratories, Inc.
Chaska, MN, US - Received
- August 21, 1992
- Decision date
- February 12, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MCE – Respiratory Syncytial Virus - Elisa
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3480
- Specialty
- Microbiology
Other 510(k)s with product code MCE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K061008 | Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199MCE · Traditional | Quidel Corp. | 09/08/2006SE |
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Questions and answers
When was Kallestad RSV Microplate Eia cleared by the FDA?
Kallestad RSV Microplate Eia (K924289) received a 510(k) decision of Substantially Equivalent on February 12, 1993, 175 days after the submission was received.
What is the product code of K924289?
The FDA product code is MCE – Respiratory Syncytial Virus - Elisa, a Class I (low risk) device regulated under 21 CFR 866.3480.