Spq(Tm) Test System for Prealbumin
FDA 510(k) K884297 · Atlantic Antibodies
510(k) numberK884297
Submission
- Device name
- Spq(Tm) Test System for Prealbumin
- Applicant
- Atlantic Antibodies
Scarborough, ME, US - Received
- October 12, 1988
- Decision date
- November 2, 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 |
| 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 |
| 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 |
|---|---|---|
| K892526 | SPQ TM Test System II for CRPDCK · Traditional | 05/09/1989SE |
| K891154 | Spq(Tm) Antibody Reagent Set II for Apo A-I/Apo BMSJ · Traditional | 03/16/1989SE |
| K890563 | Spq(Tm) Antibody Reagent Set II for TRFDDG · Traditional | 03/03/1989SE |
| K890561 | Spq(Tm) Antibody Reagent Set II for IgmCFQ · Traditional | 02/23/1989SE |
| K890562 | Spq(Tm) Antibody Reagent Set II for HPTDAD · Traditional | 02/22/1989SE |
| K890416 | Spq(Tm) Antibody Reagent Set II for IggDEW · Traditional | 02/22/1989SE |
| K890564 | Spq(Tm) Antibody Reagent Set II for C4DBI · Traditional | 02/17/1989SE |
| K890417 | Spq(Tm) Antibody Reagent Set II for C3KTQ · Traditional | 02/17/1989SE |
| K890415 | Spq(Tm) Antibody Reagent Set II for AatDEM · Traditional | 02/17/1989SE |
| K890560 | Spq(Tm) Antibody Reagent Set II for IgaCZP · Traditional | 02/15/1989SE |
Questions and answers
When was Spq(Tm) Test System for Prealbumin cleared by the FDA?
Spq(Tm) Test System for Prealbumin (K884297) received a 510(k) decision of Substantially Equivalent on November 2, 1988, 21 days after the submission was received.
What is the product code of K884297?
The FDA product code is JZJ – Prealbumin, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5060.