Prealbumin Immunological NL Test Kit
FDA 510(k) K913672 · The Binding Site, Ltd.
510(k) numberK913672
Submission
- Device name
- Prealbumin Immunological NL Test Kit
- Applicant
- The Binding Site, Ltd.
Los Angeles, CA, US - Received
- August 19, 1991
- Decision date
- December 20, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| 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 |
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Questions and answers
When was Prealbumin Immunological NL Test Kit cleared by the FDA?
Prealbumin Immunological NL Test Kit (K913672) received a 510(k) decision of Substantially Equivalent on December 20, 1991, 123 days after the submission was received.
What is the product code of K913672?
The FDA product code is JZJ – Prealbumin, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5060.