Tandem Pap Kit - (Parts I & II)
FDA 510(k) K811959 · Hybritech, Inc.
510(k) numberK811959
Submission
- Device name
- Tandem Pap Kit - (Parts I & II)
- Applicant
- Hybritech, Inc.
Mchenry, IL, US - Received
- July 9, 1981
- Decision date
- September 1, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JFH – Acid Phosphatase (Prostatic), Tartrate Inhibited
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1020
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JFH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K000257 | Immulite 2000 Pap, Models L2KPA2, L2KPA6JFH · Traditional | Diagnostic Products Corp. | 02/23/2000SE |
| K981573 | Ubi Magiwel Pap (Prostatic Acid Phosphatase) Eia QuantitatveJFH · Traditional | United Biotech, Inc. | 09/15/1998SE |
| K964756 | Prostatic Acid Phosphatase Reagent Test/Prostatic Acid Phosphatase Reagent KitJFH · Traditional | Wano-Tech Corp. | 04/23/1997SE |
| K931701 | Immulite PapJFH · Traditional | Diagnostic Products Corp. | 01/27/1994SE |
| K925377 | Imx PapJFH · Traditional | Abbott Laboratories | 01/13/1993SE |
| K921745 | Hybritech Stratus Pap Fluorometric Enzyme ImmunoJFH · Traditional | Hybritech, Inc. | 07/30/1992SE |
| K902937 | Milenia Pap Irma Catalog #: MKPA1, XJFH · Traditional | Diagnostic Products Corp. | 09/21/1990SE |
| K901933 | Coat-A-Count Pap Irma, Catlog# 1KPA1, 1KPA2JFH · Traditional | Diagnostic Products Corp. | 06/28/1990SE |
| K895723 | Irma-Count(Tm) Pap, (RKPA1, RKPA2)JFH · Traditional | Diagnostic Products Corp. | 10/31/1989SE |
| K893508 | Prostate Specific Antigen Immunohistochemical AntiJFH · Traditional | Baxter Healthcare Corp | 08/04/1989SE |
More from Baxter Healthcare Corp
| 510(k) | Device | Decision |
|---|---|---|
| K972666 | Tandem-Mp Ostase Immunoenzymetric AssayCIN · Traditional | 09/11/1997SE |
| K961573 | Tandem-R Ostase Immunoradiometric AssayCIN · Traditional | 08/19/1996SE |
| K930810 | Tandem-R Ostase Immunoradiometric AssayCIN · Traditional | 01/11/1994SE |
| K922754 | Tandem-E Ige II Calibration Verification SetJJX · Traditional | 02/17/1993SE |
| K921745 | Hybritech Stratus Pap Fluorometric Enzyme ImmunoJFH · Traditional | 07/30/1992SE |
| K921252 | Tandem-E Ferritin Calibration Verification ConrolJJX · Traditional | 07/17/1992SE |
| K920556 | Tandem-E HCG Calibration Verification Control SetJJX · Traditional | 07/17/1992SE |
| K921763 | Tandem Icon QSR CKMB Immunoenzymetric AssayJHY · Traditional | 06/09/1992SE |
| K912439 | Tandem-E TSH Calibration Verification Control SetJJX · Traditional | 08/28/1991SE |
| K911417 | Icon Strep B Immunoenzymetric AssayGTZ · Traditional | 07/24/1991SE |
Questions and answers
When was Tandem Pap Kit - (Parts I & II) cleared by the FDA?
Tandem Pap Kit - (Parts I & II) (K811959) received a 510(k) decision of Substantially Equivalent on September 1, 1981, 54 days after the submission was received.
What is the product code of K811959?
The FDA product code is JFH – Acid Phosphatase (Prostatic), Tartrate Inhibited, a Class II (moderate risk) device regulated under 21 CFR 862.1020.