Cell-Matics Herpes Simplex Virus Detect
FDA 510(k) K840366 · Difco Laboratories, Inc.
510(k) numberK840366
Submission
- Device name
- Cell-Matics Herpes Simplex Virus Detect
- Applicant
- Difco Laboratories, Inc.
Detroit, MI, US - Received
- January 27, 1984
- Decision date
- January 8, 1985
- 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
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| K973211 | Fresh Cells MV1LUKIR · Traditional | Diagnostic Hybrids, Inc. | 09/25/1997SE |
| K973210 | Fresh Cells Nci H292KIR · Traditional | Diagnostic Hybrids, Inc. | 09/25/1997SE |
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| 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 |
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| K953129 | Esp Culture System - MycoMDB · Traditional | 12/26/1995SE |
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| K944275 | Dispens-O-Disc Piperacillin 100 Mcg./Tazobactam 10 Mcg.JTN · Traditional | 12/19/1994SE |
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Questions and answers
When was Cell-Matics Herpes Simplex Virus Detect cleared by the FDA?
Cell-Matics Herpes Simplex Virus Detect (K840366) received a 510(k) decision of Substantially Equivalent on January 8, 1985, 347 days after the submission was received.
What is the product code of K840366?
The FDA product code is KIR – Cells, Animal And Human, Cultured, a Class I (low risk) device regulated under 21 CFR 864.2280.