Rabbit Kidney Culture Cells (First Pass)
FDA 510(k) K871033 · Microscan Div. Baxter Healthcare Corp.
510(k) numberK871033
Submission
- Device name
- Rabbit Kidney Culture Cells (First Pass)
- Applicant
- Microscan Div. Baxter Healthcare Corp.
West Sacramento, CA, US - Received
- March 16, 1987
- Decision date
- March 31, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KIR – Cells, Animal And Human, Cultured
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.2280
- Specialty
- Hematology
Other 510(k)s with product code KIR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K973214 | Fresh Cells HFFKIR · Traditional | Diagnostic Hybrids, Inc. | 09/25/1997SE |
| K973213 | Fresh Cells LLC-MK2KIR · Traditional | Diagnostic Hybrids, Inc. | 09/25/1997SE |
| K973212 | Fresh Cells WI-38KIR · Traditional | Diagnostic Hybrids, Inc. | 09/25/1997SE |
| K973211 | Fresh Cells MV1LUKIR · Traditional | Diagnostic Hybrids, Inc. | 09/25/1997SE |
| K973210 | Fresh Cells Nci H292KIR · Traditional | Diagnostic Hybrids, Inc. | 09/25/1997SE |
| K973209 | Fresh Cells VeroKIR · Traditional | Diagnostic Hybrids, Inc. | 09/25/1997SE |
| K971508 | RHMK II Cell Culture, an Expanded Primary Rhesus Monkey Kidney Cell CultureKIR · Traditional | Bio-Whittaker, Inc., A Cambrex Co. | 09/17/1997SE |
| K972414 | FreshcellsKIR · Traditional | Diagnostic Hybrids, Inc. | 08/29/1997SE |
| K965047 | Mink Lung Cell CultureKIR · Traditional | Neogenex | 02/04/1997SE |
| K962782 | Freshfrozen Cells, HEP-2KIR · Traditional | Diagnostic Hybrids, Inc. | 08/29/1996SE |
More from Diagnostic Hybrids, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K871234 | Antibody Assay for Detect. of Parainfluenza Type 1GQS · Traditional | 06/26/1987SE |
| K871233 | Antibody Assay for Detection of Influenza aGNX · Traditional | 06/26/1987SE |
| K871232 | Antibody Assay for Detect. of Parainfluenza Type 3GQS · Traditional | 06/26/1987SE |
| K871231 | Antibody Assay for Detection of Influenza BGNX · Traditional | 06/26/1987SE |
| K871230 | Antibody Assay for Detec. of Resp. Syncytial VirusLKT · Traditional | 06/26/1987SE |
| K871229 | Antibody Assay for Detection of Adenovirus in CellGOD · Traditional | 06/26/1987SE |
| K871228 | Antibody Assay for Detect. of Parainfluenza Type 2GQS · Traditional | 06/26/1987SE |
| K870814 | Herpes Simplex Antibody Test for Dect. of HSV 1&2GQL · Traditional | 06/04/1987SE |
| K870074 | Gram Negative and Gram Positive Mic/Combo PanelsJWY · Traditional | 04/14/1987SE |
| K870089 | Immunoscan(Tm) Direct Neisseria Meningitidis KitGTJ · Traditional | 03/17/1987SE |
Questions and answers
When was Rabbit Kidney Culture Cells (First Pass) cleared by the FDA?
Rabbit Kidney Culture Cells (First Pass) (K871033) received a 510(k) decision of Substantially Equivalent on March 31, 1987, 15 days after the submission was received.
What is the product code of K871033?
The FDA product code is KIR – Cells, Animal And Human, Cultured, a Class I (low risk) device regulated under 21 CFR 864.2280.