N Antiserum to Human Transferrin
FDA 510(k) K972840 · Behring Diagnostics, Inc.
510(k) numberK972840
Submission
- Device name
- N Antiserum to Human Transferrin
- Applicant
- Behring Diagnostics, Inc.
Westwood, MA, US - Received
- August 1, 1997
- Decision date
- October 17, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DDG – Transferrin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5880
- Specialty
- Immunology
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More from Dade Behring, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K973832 | Opus HLH ControlsJJX · Traditional | 10/27/1997SE |
| K972929 | N Antiserum to Human AlbuminDCF · Traditional | 10/20/1997SE |
| K973202 | Modification of Opus Ferritin Test SystemDBF · Traditional | 09/12/1997SE |
| K972316 | Opus D-DimerGHH · Traditional | 09/09/1997SE |
| K972116 | Von Willebrand ReagentGGP · Traditional | 07/25/1997SE |
| K972011 | Opus EthanolDIC · Traditional | 07/22/1997SE |
| K971600 | Emit Calibrator B Level 1 (Cutoff)/Emit Calibrator B Level 2 (High)DKB · Traditional | 06/25/1997SE |
| K971596 | Emit II Opiates 300/2000 AssayDJG · Traditional | 06/25/1997SE |
| K964595 | Opus Psa Test SystemLTJ · Traditional | 06/24/1997SE |
| K971725 | Opus ProgesteroneJLS · Traditional | 06/18/1997SE |
Questions and answers
When was N Antiserum to Human Transferrin cleared by the FDA?
N Antiserum to Human Transferrin (K972840) received a 510(k) decision of Substantially Equivalent on October 17, 1997, 77 days after the submission was received.
What is the product code of K972840?
The FDA product code is DDG – Transferrin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5880.