Las-R Human Prealbumin Test
FDA 510(k) K772329 · Hyland Therapeutic Div., Travenol Laboratories
510(k) numberK772329
Submission
- Device name
- Las-R Human Prealbumin Test
- Applicant
- Hyland Therapeutic Div., Travenol Laboratories
Mchenry, IL, US - Received
- December 21, 1977
- Decision date
- February 3, 1978
- 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 |
| K851912 | Laser Prealbumin TestJZJ · Traditional | Behring Diagnostics, Inc. | 06/21/1985SE |
| K821135 | Prealbumin Enzyme ImmunoassayJZJ · Traditional | Abbott Laboratories | 05/05/1983SE |
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| K812220 | Nephelometric Solid Turbidity StandardJIW · Traditional | 08/18/1981SE |
| K810078 | Q-Pak Therapeutic Drug Monit. Control SDIF · Traditional | 02/02/1981SE |
| K810077 | Omega Therapeutic Drug Monit. Control S.DIF · Traditional | 01/28/1981SE |
| K802610 | Alert A,Hdl-Apoliporotein a, Test KitDER · Traditional | 01/05/1981SE |
| K791113 | Low Ionic Strength Solution (Liss)KSG · Traditional | 06/28/1979SE |
| K790249 | Test CellsKSF · Traditional | 05/16/1979SE |
| K781225 | Globulin Test, Human Thyroxine BindingCEE · Traditional | 08/31/1978SE |
| K780962 | Automated EnzymeKSK · Traditional | 07/27/1978SE |
Questions and answers
When was Las-R Human Prealbumin Test cleared by the FDA?
Las-R Human Prealbumin Test (K772329) received a 510(k) decision of Substantially Equivalent on February 3, 1978, 44 days after the submission was received.
What is the product code of K772329?
The FDA product code is JZJ – Prealbumin, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5060.