Laser Prealbumin Test
FDA 510(k) K851912 · Behring Diagnostics, Inc.
510(k) numberK851912
Submission
- Device name
- Laser Prealbumin Test
- Applicant
- Behring Diagnostics, Inc.
La Jolla, CA, US - Received
- May 1, 1985
- Decision date
- June 21, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JZJ – Prealbumin, Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5060
- Specialty
- Immunology
Other 510(k)s with product code JZJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K000661 | Randox PrealbuminJZJ · Traditional | Randox Laboratories, Ltd. | 04/13/2000SE |
| K972638 | Tina-Quant PrealbuminJZJ · Traditional | Boehringer Mannheim Corp. | 01/09/1998SE |
| K951966 | Human Prealbumin Radial Immunodiffusion KitJZJ · Traditional | Kent Laboratories, Inc. | 06/01/1995SE |
| K913672 | Prealbumin Immunological NL Test KitJZJ · Traditional | The Binding Site, Ltd. | 12/20/1991SE |
| K884298 | Spq(Tm) Test System for MicroalbuminJZJ · Traditional | Atlantic Antibodies | 11/02/1988SE |
| K884297 | Spq(Tm) Test System for PrealbuminJZJ · Traditional | Atlantic Antibodies | 11/02/1988SE |
| K883002 | QM300 Prealbumin Antibody PackJZJ · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 09/22/1988SE |
| K850686 | Antiserum to Human PrealbuminJZJ · Traditional | Kent Laboratories, Inc. | 11/01/1985SE |
| K821135 | Prealbumin Enzyme ImmunoassayJZJ · Traditional | Abbott Laboratories | 05/05/1983SE |
| K772329 | Las-R Human Prealbumin TestJZJ · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 02/03/1978SE |
More from Hyland Therapeutic Div., Travenol Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K973832 | Opus HLH ControlsJJX · Traditional | 10/27/1997SE |
| K972929 | N Antiserum to Human AlbuminDCF · Traditional | 10/20/1997SE |
| K972840 | N Antiserum to Human TransferrinDDG · Traditional | 10/17/1997SE |
| 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 |
Questions and answers
When was Laser Prealbumin Test cleared by the FDA?
Laser Prealbumin Test (K851912) received a 510(k) decision of Substantially Equivalent on June 21, 1985, 51 days after the submission was received.
What is the product code of K851912?
The FDA product code is JZJ – Prealbumin, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5060.