QM300 Prealbumin Antibody Pack
FDA 510(k) K883002 · Kallestad Diag, A Div. of Erbamont, Inc.
510(k) numberK883002
Submission
- Device name
- QM300 Prealbumin Antibody Pack
- Applicant
- Kallestad Diag, A Div. of Erbamont, Inc.
Chaska, MN, US - Received
- July 18, 1988
- Decision date
- September 22, 1988
- 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 |
| K850686 | Antiserum to Human PrealbuminJZJ · Traditional | Kent Laboratories, Inc. | 11/01/1985SE |
| K851912 | Laser Prealbumin TestJZJ · Traditional | Behring Diagnostics, Inc. | 06/21/1985SE |
| 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 |
|---|---|---|
| K910887 | QM300 Control G PackGTQ · Traditional | 06/17/1991SE |
| K910886 | QM300 Antistreptolysin O (Aso) Antigen PackGTQ · Traditional | 06/17/1991SE |
| K910885 | QM300 Calibrator G PackGTQ · Traditional | 06/17/1991SE |
| K904725 | Chlamydia System Software (CSS)LJC · Traditional | 01/14/1991SE |
| K902253 | Pathfinder(Tm) Chlamydia Microplate KitLJC · Traditional | 07/26/1990SE |
| K902462 | Modified QM300 Rheumatoid Factor TestDHR · Traditional | 06/21/1990SE |
| K900010 | NDS Cortisol Test Kit and NDS Cortisol CalibratorJFT · Traditional | 04/03/1990SE |
| K900009 | NDS Theophylline Test Kit & NDS TDM Calibrator SetKLS · Traditional | 03/29/1990SE |
| K897072 | NDS Thyroxine Test Kit & NDS Thyroxine CalibratorKLI · Traditional | 03/29/1990SE |
| K894947 | Platelia Toxo Igg KitLGO · Traditional | 03/23/1990SE |
Questions and answers
When was QM300 Prealbumin Antibody Pack cleared by the FDA?
QM300 Prealbumin Antibody Pack (K883002) received a 510(k) decision of Substantially Equivalent on September 22, 1988, 66 days after the submission was received.
What is the product code of K883002?
The FDA product code is JZJ – Prealbumin, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5060.