Lyphochek Immunoassay Serum Control Level I,Ii,Iii
FDA 510(k) K864137 · Bio-Rad
510(k) numberK864137
Submission
- Device name
- Lyphochek Immunoassay Serum Control Level I,Ii,Iii
- Applicant
- Bio-Rad
Richmond, CA, US - Received
- October 21, 1986
- Decision date
- November 7, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KIJ – Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
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| K951450 | System 2000 Replacement Battery, System 2000-EXTENDED Run Replacement BatteryKIJ · Traditional | Strenumed, Inc. | 05/17/1995SE |
| K944488 | S & S Orthopedic Wire Driver 701KIJ · Traditional | S & S Orthopedic , Ltd. | 03/02/1995SE |
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Questions and answers
When was Lyphochek Immunoassay Serum Control Level I,Ii,Iii cleared by the FDA?
Lyphochek Immunoassay Serum Control Level I,Ii,Iii (K864137) received a 510(k) decision of Substantially Equivalent on November 7, 1986, 17 days after the submission was received.
What is the product code of K864137?
The FDA product code is KIJ – Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment, a Class I (low risk) device regulated under 21 CFR 878.4820.