510(k) K760031
- Device
- HISTOCHEMICAL PAS REACTION SET
- Applicant
- HARLECO
- 510(k) number
- K760031
- Product code
- HZT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-07-20
- Date received
- 1976-06-14
- Regulation
- 864.1850
- Classification name
- Reagent, Schiff
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1125908
- 2083544
- 2022180
- 2916205
- 1640981
- 1625587
- 1831638
- 3017970519
- 1045125
- 1419699
- 1550222
- 1219125
- 9610140
- 3004074729
- 3002805583
- 3015614371
- 3006365273
- 3008174888
- 2028492
- 3007496191
- 3009963993
- 2247035
- 3008776165
- 3009189893
- 2013736
- 2250039
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HZT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K883217 | SCHIFF REAGENT | Surgipath Medical Industries, Inc. | 1988-08-05 |
| K843752 | SIGMA PERIODIC ACID-SCHIFF STAIN 395 | Sigma Chemical Co. | 1984-10-30 |
| K842919 | SCHIFF REAGENT FUCHSIN-SULFUROUS ACID | E K Ind., Inc. | 1984-09-11 |
| K842917 | SCHIFF REAGENT, PAS STAIN | E K Ind., Inc. | 1984-09-07 |
Legacy Summary#
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FDA Review#
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