Rabbit Complement
FDA 510(k) K791117 · Calbiochem-Behring Corp.
510(k) numberK791117
Submission
- Device name
- Rabbit Complement
- Applicant
- Calbiochem-Behring Corp.
Mchenry, IL, US - Received
- June 15, 1979
- Decision date
- August 3, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KTQ – Reagent, Complement
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.4100
- Specialty
- Immunology
Other 510(k)s with product code KTQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K890417 | Spq(Tm) Antibody Reagent Set II for C3KTQ · Traditional | Atlantic Antibodies | 02/17/1989SE |
| K812522 | Rabbit ComplementKTQ · Traditional | Dutchland Laboratories, Inc. | 09/23/1981SE |
| K812370 | Guinea Pig Complement RegularKTQ · Traditional | Dutchland Laboratories, Inc. | 09/08/1981SE |
| K812369 | Guinea Pig Complement Virus AntibodyKTQ · Traditional | Dutchland Laboratories, Inc. | 09/08/1981SE |
| K790380 | Low-Tox-H Rabbit ComplementKTQ · Traditional | Cederlane Labs , Ltd. | 03/21/1979SE |
More from Cederlane Labs , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K831811 | Revolution Radial Immunodiffusion PlateJZQ · Traditional | 07/28/1983SE |
| K831036 | Ena Test Kit SM & RNP Auto AntibodyLLL · Traditional | 04/27/1983SE |
| K830214 | Aft System IIIDHN · Traditional | 03/09/1983SE |
| K820812 | Creatine Kinase-Mb KitJHY · Traditional | 04/12/1982SE |
| K813493 | Enzygnost TM Rubella IgmLFX · Traditional | 03/04/1982SE |
| K820088 | Aft System Proficiency Testing ProgramDBL · Traditional | 01/26/1982SE |
| K812458 | PadacJTO · Traditional | 09/23/1981SE |
| K810718 | C-Peptice ReagentsJKD · Traditional | 03/31/1981SE |
| K810669 | Pantrak E.K.CIW · Traditional | 03/31/1981SE |
| K810404 | Rheumatoid Factors Reference SerumDHR · Traditional | 03/11/1981SE |
Questions and answers
When was Rabbit Complement cleared by the FDA?
Rabbit Complement (K791117) received a 510(k) decision of Substantially Equivalent on August 3, 1979, 49 days after the submission was received.
What is the product code of K791117?
The FDA product code is KTQ – Reagent, Complement, a Class I (low risk) device regulated under 21 CFR 866.4100.