Guinea Pig Complement Virus Antibody
FDA 510(k) K812369 · Dutchland Laboratories, Inc.
510(k) numberK812369
Submission
- Device name
- Guinea Pig Complement Virus Antibody
- Applicant
- Dutchland Laboratories, Inc.
Mchenry, IL, US - Received
- August 20, 1981
- Decision date
- September 8, 1981
- 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 |
| K791117 | Rabbit ComplementKTQ · Traditional | Calbiochem-Behring Corp. | 08/03/1979SE |
| K790380 | Low-Tox-H Rabbit ComplementKTQ · Traditional | Cederlane Labs , Ltd. | 03/21/1979SE |
More from Cederlane Labs , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K821919 | Powdered RPMI-1634 MediumKIT · Traditional | 07/27/1982SE |
| K821918 | Powdered RPMI-1603 MediumKIT · Traditional | 07/27/1982SE |
| K821917 | Waymouth's Powder MediumKIT · Traditional | 07/27/1982SE |
| K821916 | Improved Mem-Richter's Powder Modif.KIT · Traditional | 07/27/1982SE |
| K821915 | Bme Autoclavable MediumKIT · Traditional | 07/27/1982SE |
| K821914 | Coon's F-12 Powder MediumKIT · Traditional | 07/27/1982SE |
| K821913 | Iscove's Modified Dulbecco Powder MediumKIT · Traditional | 07/27/1982SE |
| K821912 | Mccoy's Powder Medium 5A SuspensionKIT · Traditional | 07/27/1982SE |
| K821911 | S-Mem-Joklik's PowderKIT · Traditional | 07/27/1982SE |
| K820931 | Hank's 199 Powdered MediumKIT · Traditional | 04/21/1982SE |
Questions and answers
When was Guinea Pig Complement Virus Antibody cleared by the FDA?
Guinea Pig Complement Virus Antibody (K812369) received a 510(k) decision of Substantially Equivalent on September 8, 1981, 19 days after the submission was received.
What is the product code of K812369?
The FDA product code is KTQ – Reagent, Complement, a Class I (low risk) device regulated under 21 CFR 866.4100.